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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, imaging, pulsed echo, ultrasonic
Product CodeIYO
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUTOME, INC.
  SUBSTANTIALLY EQUIVALENT 2
ADECHO TECH
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALOKA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ARCSCAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARDENT SOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTSONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
B-K MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 2
BARD ACCESS SYSTEMS, INC, (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BIIM ULTRASOUND AS
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARENOSO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARESONO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CERACARTA SPA
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS CO INC DBA CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DBMEDX INC.
  SUBSTANTIALLY EQUIVALENT 1
DELPHINUS MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DELPHINUS MEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
DGH TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 11
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDGECARE INC.
  SUBSTANTIALLY EQUIVALENT 1
EIELING TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELLEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEM ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS CHINA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE VINGMED ULTRASOUND AS
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HALO MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMACOR INC.
  SUBSTANTIALLY EQUIVALENT 1
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEROPTIC TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 2
ISONO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 3
LEIKER REGULATORY & QUALITY CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LILIUM OTSUKA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAUI IMAGING
  SUBSTANTIALLY EQUIVALENT 1
MCUBE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
MEDA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
MEDA CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDNOVEL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
METRITRACK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MOBISANTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVIFUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OPKO INSTRUMENTATION, INC
  SUBSTANTIALLY EQUIVALENT 1
OREON TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
PANASONIC HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS VOLCANO
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
QT ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 2
QT ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
QUANTEL MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
QUANTEL S.A.
  SUBSTANTIALLY EQUIVALENT 1
RIVANNA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SASET (CHENGDU) INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO
  SUBSTANTIALLY EQUIVALENT 1
SIGNOSTICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SIGNOSTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNOSTICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SOMA ACCESS SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 3
SONIVATE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
SONOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONOSCAPE COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LISCHKA MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIHAO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEMED
  SUBSTANTIALLY EQUIVALENT 2
THD SPA
  SUBSTANTIALLY EQUIVALENT 2
THE PROMETHEUS GROUP
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRASONIX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULTRASOUND MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERATHON INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
VITACON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINPROBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 303 303
2015 268 268
2016 253 253
2017 238 238
2018 368 368
2019 537 537
2020 498 620
2021 617 739
2022 511 511
2023 527 527
2024 170 170

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1086 1086
Retraction Problem 736 736
No Apparent Adverse Event 410 410
Defective Component 377 377
Battery Problem 356 356
Loss of Power 342 342
Unexpected Shutdown 261 261
Break 255 255
Application Program Freezes, Becomes Nonfunctional 171 171
No Display/Image 115 115
Contamination /Decontamination Problem 87 87
Image Display Error/Artifact 77 77
Data Problem 77 77
Device Operates Differently Than Expected 51 51
Incorrect Measurement 49 49
Premature Discharge of Battery 45 45
Sharp Edges 43 43
Charging Problem 42 42
Computer Software Problem 41 41
Loss of Data 38 38
Erratic or Intermittent Display 35 35
Device Displays Incorrect Message 34 156
Difficult or Delayed Activation 29 29
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Failure to Power Up 26 26
Failure to Charge 25 25
Display or Visual Feedback Problem 24 24
Adverse Event Without Identified Device or Use Problem 24 146
Crack 23 23
Failure to Align 22 22
Imprecision 19 19
Appropriate Term/Code Not Available 17 17
False Reading From Device Non-Compliance 15 15
Signal Artifact/Noise 14 14
Thermal Decomposition of Device 14 14
Operating System Becomes Nonfunctional 14 14
Output Problem 13 13
Malposition of Device 12 12
Electrical /Electronic Property Problem 12 12
Loose or Intermittent Connection 12 12
Failure to Read Input Signal 11 11
Smoking 11 11
Fire 11 11
Noise, Audible 11 11
Therapeutic or Diagnostic Output Failure 11 11
Fracture 10 10
Inaccurate Synchronization 10 10
Defective Device 10 10
Incorrect Or Inadequate Test Results 10 10
Device Sensing Problem 10 10
Inappropriate/Inadequate Shock/Stimulation 9 9
Computer Operating System Problem 9 9
Improper or Incorrect Procedure or Method 8 8
Component Missing 8 8
Power Problem 8 8
Device Inoperable 8 8
Device Stops Intermittently 7 7
Connection Problem 7 7
Insufficient Information 7 7
Calibration Problem 6 6
Use of Device Problem 6 6
Material Separation 6 6
Mechanical Problem 6 6
Device Emits Odor 6 6
Overheating of Device 6 6
Fluid/Blood Leak 6 6
Circuit Failure 5 5
Application Program Problem 5 5
Sparking 5 5
Mechanics Altered 5 5
Material Integrity Problem 5 5
Device Operational Issue 5 5
Failure to Shut Off 5 5
Temperature Problem 5 5
Intermittent Loss of Power 5 5
Improper Device Output 4 4
Positioning Problem 4 4
Split 4 4
Communication or Transmission Problem 4 4
Application Interface Becomes Non-Functional Or Program Exits Abnormally 4 4
No Device Output 4 4
Self-Activation or Keying 4 4
Inadequacy of Device Shape and/or Size 3 3
Failure to Run on Battery 3 3
Electromagnetic Interference 3 3
Intermittent Continuity 3 3
Electro-Static Discharge 3 3
Compatibility Problem 3 3
Measurement System Incompatibility 3 3
Mechanical Jam 3 3
Device Contamination with Chemical or Other Material 3 3
Delayed Program or Algorithm Execution 3 3
Material Split, Cut or Torn 3 3
Device Fell 2 2
Explosion 2 2
Scratched Material 2 2
Patient Data Problem 2 2
Electrical Shorting 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1855 1977
No Consequences Or Impact To Patient 1654 1654
No Known Impact Or Consequence To Patient 714 714
No Patient Involvement 136 136
No Information 42 42
Insufficient Information 41 41
Postoperative refraction, unexpected 13 13
No Code Available 11 11
Obstruction/Occlusion 10 10
Thrombus 10 10
Erythema 6 6
Discomfort 5 5
Cardiac Perforation 5 5
Electric Shock 5 5
Death 4 4
Hemorrhage/Bleeding 4 4
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Failure of Implant 3 3
Unspecified Infection 3 3
Nerve Damage 3 3
Pain 3 3
Perforation 3 125
Overcorrection 3 3
Vascular Dissection 3 3
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 2 2
Perforation of Vessels 2 2
Burn, Thermal 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Skin Inflammation 2 2
Needle Stick/Puncture 2 2
Visual Impairment 2 2
Abrasion 2 2
Hypersensitivity/Allergic reaction 2 2
Local Reaction 2 2
Respiratory Distress 1 1
ST Segment Elevation 1 1
Shock 1 1
Skin Irritation 1 1
Swelling 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Retention 1 1
Uterine Perforation 1 1
Pneumothorax 1 1
Rash 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Angina 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Chest Pain 1 1
Congenital Defect/Deformity 1 1
Corneal Abrasion 1 1
Abdominal Pain 1 1
Dysphagia/ Odynophagia 1 1
Electrocution 1 1
Fatigue 1 1
Fistula 1 1
Headache 1 1
Vomiting 1 1
Burning Sensation 1 1
Great Vessel Perforation 1 1
Dizziness 1 1
Anaphylactoid 1 1
Excessive Tear Production 1 1
Ulcer 1 1
Urticaria 1 1
Anxiety 1 1
Aortic Dissection 1 1
Inadequate Pain Relief 1 1
Perforation of Esophagus 1 1
Reaction 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Complete Heart Block 1 1
Blurred Vision 1 1
Dysuria 1 1
Superficial (First Degree) Burn 1 1
Pregnancy 1 1
Eye Pain 1 1
Contact Dermatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Company II Nov-23-2019
2 Civco Medical Instruments Co. Inc. II Dec-20-2021
3 Civco Medical Instruments Inc II Jul-06-2012
4 ECOLAB INC III Jul-13-2018
5 GE Healthcare, LLC II Jan-24-2022
6 GE Healthcare, LLC II Nov-21-2013
7 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
8 GE Medical Systems, LLC II Dec-16-2009
9 GE Medical Systems, LLC II Nov-09-2009
10 Parker Laboratories, Inc. II May-09-2018
11 Parker Laboratories, Inc. II Oct-29-2014
12 Philips Ultrasound Inc II Sep-17-2021
13 Siemens Medical Solutions USA, Inc. II May-05-2015
14 Siemens Medical Solutions USA, Inc. II Feb-07-2015
15 Siemens Medical Solutions USA, Inc. II Mar-09-2013
16 Siemens Medical Solutions USA, Inc. II May-30-2012
17 Siemens Medical Solutions USA, Inc. II May-06-2011
18 Siemens Medical Solutions USA, Inc. II Apr-25-2011
19 Siemens Medical Solutions USA, Inc. II Apr-04-2011
20 Siemens Medical Solutions USA, Inc. II Feb-01-2011
21 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
22 Soma Access Systems LLC II Dec-16-2014
23 SonoSite, Inc. II Oct-18-2013
24 Sonogage Inc II Sep-16-2013
25 Sonosite, Inc. II Aug-09-2010
26 Toshiba American Medical Systems Inc II Aug-10-2011
27 Toshiba American Medical Systems Inc II Mar-03-2011
28 Toshiba American Medical Systems Inc II Jul-06-2010
29 Toshiba American Medical Systems Inc II Mar-11-2010
30 Verathon, Inc. II Mar-10-2016
31 Verathon, Inc. II Oct-04-2010
32 Verathon, Inc. II Sep-17-2009
33 Volcano Corp III Apr-09-2022
34 Volcano Corp II Jul-08-2015
35 Volcano Corporation II Dec-12-2019
36 Volcano Corporation II May-17-2018
37 Volcano Corporation II Jul-20-2015
38 Volcano Corporation II Sep-10-2012
39 Volcano Corporation II Feb-07-2012
40 Volcano Corporation II Nov-01-2010
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