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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
AVANTSONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC, (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DELPHINUS MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISONO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIGHTMED USA, INC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAUI IMAGING
  SUBSTANTIALLY EQUIVALENT 1
MCUBE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
MEDNOVEL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
METRITRACK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NAVIFUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
QT ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 1
QT ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 3
SONIVATE MEDICAL INC
  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
THD SPA
  SUBSTANTIALLY EQUIVALENT 2
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
  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
2018 368 368
2019 537 537
2020 498 620
2021 617 739
2022 511 511
2023 446 446

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 923 923
Battery Problem 356 356
No Apparent Adverse Event 342 342
Loss of Power 339 339
Defective Component 334 334
Unexpected Shutdown 242 242
Break 218 218
Application Program Freezes, Becomes Nonfunctional 150 150
No Display/Image 108 108
Contamination /Decontamination Problem 87 87
Retraction Problem 86 86
Image Display Error/Artifact 73 73
Data Problem 56 56
Premature Discharge of Battery 44 44
Charging Problem 42 42
Computer Software Problem 33 33
Erratic or Intermittent Display 30 30
Sharp Edges 30 30
Failure to Charge 25 25
Difficult or Delayed Activation 25 25
Display or Visual Feedback Problem 20 20
Crack 19 19
Failure to Align 19 19
Failure to Power Up 19 19
Imprecision 17 17
Device Operates Differently Than Expected 14 14
Device Displays Incorrect Message 12 134
Appropriate Term/Code Not Available 12 12
Operating System Becomes Nonfunctional 12 12
Signal Artifact/Noise 12 12
Thermal Decomposition of Device 11 11
Failure to Read Input Signal 11 11
Therapeutic or Diagnostic Output Failure 11 11
Loss of Data 10 10
Device Sensing Problem 10 10
Defective Device 9 9
Loose or Intermittent Connection 9 9
Electrical /Electronic Property Problem 8 8
Power Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 130
Noise, Audible 8 8
Malposition of Device 7 7
Fire 7 7
Smoking 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Device Stops Intermittently 6 6
Computer Operating System Problem 5 5
Failure to Shut Off 5 5
Output Problem 5 5
Intermittent Loss of Power 5 5
Sparking 4 4
Application Program Problem 4 4
Component Missing 4 4
Mechanical Problem 4 4
Fluid/Blood Leak 4 4
Electromagnetic Interference 3 3
Intermittent Continuity 3 3
Incorrect Measurement 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
No Device Output 3 3
Overheating of Device 3 3
Failure to Run on Battery 3 3
Self-Activation or Keying 3 3
Use of Device Problem 3 3
Connection Problem 3 3
Delayed Program or Algorithm Execution 3 3
Temperature Problem 3 3
Material Split, Cut or Torn 3 3
Device Fell 2 2
Explosion 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Calibration Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Device Operational Issue 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Measurement System Incompatibility 2 2
Radiofrequency Interference (RFI) 2 2
Product Quality Problem 2 2
Device Emits Odor 2 2
Material Discolored 2 2
Display Difficult to Read 2 2
Charred 2 2
Image Orientation Incorrect 2 2
Material Frayed 2 2
Grounding Malfunction 1 1
Image Resolution Poor 1 1
False Reading From Device Non-Compliance 1 1
Leak/Splash 1 1
Delayed Alarm 1 1
Device Alarm System 1 1
Contamination 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Peeled/Delaminated 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1581 1703
No Consequences Or Impact To Patient 1022 1022
No Known Impact Or Consequence To Patient 550 550
No Patient Involvement 22 22
No Information 18 18
Insufficient Information 13 13
Erythema 5 5
Discomfort 4 4
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pain 3 3
Complaint, Ill-Defined 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Vascular Dissection 2 2
Electric Shock 2 2
Cardiac Perforation 2 2
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
No Code Available 1 1
Eye Pain 1 1
Infiltration into Tissue 1 1
Anxiety 1 1
Injury 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Aortic Dissection 1 1
Perforation 1 123
Rash 1 1
Shock 1 1
Skin Irritation 1 1
Swelling 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Vomiting 1 1
Dizziness 1 1
Fatigue 1 1
Fistula 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
Abrasion 1 1
Angina 1 1
Burn(s) 1 1
Death 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 ECOLAB INC III Jul-13-2018
4 GE Healthcare, LLC II Jan-24-2022
5 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
6 Parker Laboratories, Inc. II May-09-2018
7 Philips Ultrasound Inc II Sep-17-2021
8 Volcano Corp III Apr-09-2022
9 Volcano Corporation II Dec-12-2019
10 Volcano Corporation II May-17-2018
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