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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.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 3
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 4
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDGECARE INC.
  SUBSTANTIALLY EQUIVALENT 1
EIELING TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISONO HEALTH, 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
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 4
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
ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 537 537
2020 498 620
2021 617 739
2022 511 511
2023 527 527
2024 396 396

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1177 1177
No Apparent Adverse Event 454 454
Defective Component 396 396
Battery Problem 334 334
Loss of Power 319 319
Unexpected Shutdown 272 272
Break 250 250
Application Program Freezes, Becomes Nonfunctional 181 181
Contamination /Decontamination Problem 87 87
No Display/Image 76 76
Data Problem 68 68
Image Display Error/Artifact 49 49
Sharp Edges 49 49
Premature Discharge of Battery 44 44
Charging Problem 37 37
Computer Software Problem 31 31
Difficult or Delayed Activation 27 27
Failure to Charge 23 23
Imprecision 20 20
Crack 16 16
Failure to Power Up 15 15
Failure to Align 14 14
Therapeutic or Diagnostic Output Failure 11 11
Display or Visual Feedback Problem 11 11
Failure to Read Input Signal 10 10
Loose or Intermittent Connection 10 10
Device Sensing Problem 10 10
Erratic or Intermittent Display 10 10
Device Displays Incorrect Message 8 130
Signal Artifact/Noise 7 7
Smoking 7 7
Electrical /Electronic Property Problem 7 7
Appropriate Term/Code Not Available 6 6
Adverse Event Without Identified Device or Use Problem 6 128
Inappropriate/Inadequate Shock/Stimulation 6 6
Defective Device 6 6
Operating System Becomes Nonfunctional 6 6
Computer Operating System Problem 5 5
Fluid/Blood Leak 5 5
Power Problem 5 5
Mechanical Problem 5 5
Fire 4 4
Output Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Intermittent Loss of Power 4 4
Noise, Audible 3 3
Failure to Run on Battery 3 3
Component Missing 3 3
Overheating of Device 3 3
Delayed Program or Algorithm Execution 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2042 2164
No Consequences Or Impact To Patient 918 918
No Known Impact Or Consequence To Patient 329 329
Insufficient Information 8 8
No Information 6 6
Erythema 5 5
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pain 3 3
Hypersensitivity/Allergic reaction 2 2
Abrasion 2 2
No Patient Involvement 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
Fatigue 1 1
Dizziness 1 1
Perforation 1 123
Chemical Exposure 1 1
Aortic Dissection 1 1
Confusion/ Disorientation 1 1
Burn(s) 1 1
Rash 1 1
Needle Stick/Puncture 1 1
Chest Pain 1 1
Vomiting 1 1
Anaphylactic Shock 1 1
Stenosis 1 1
Anxiety 1 1
Headache 1 1
Infiltration into Tissue 1 1
Eye Pain 1 1
Urinary Tract Infection 1 1
Ambulation Difficulties 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 GE Healthcare, LLC II Jan-24-2022
4 Philips Ultrasound Inc II Sep-17-2021
5 Volcano Corp III Apr-09-2022
6 Volcano Corporation II Dec-12-2019
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