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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 (SHENZHEN) LIMITED
  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
VERDURE IMAGING
  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 532 532

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1265 1265
No Apparent Adverse Event 479 479
Defective Component 410 410
Battery Problem 334 334
Loss of Power 319 319
Unexpected Shutdown 279 279
Break 257 257
Application Program Freezes, Becomes Nonfunctional 194 194
Contamination /Decontamination Problem 87 87
No Display/Image 77 77
Data Problem 71 71
Sharp Edges 52 52
Image Display Error/Artifact 49 49
Premature Discharge of Battery 44 44
Charging Problem 37 37
Computer Software Problem 31 31
Difficult or Delayed Activation 30 30
Failure to Charge 23 23
Imprecision 20 20
Crack 16 16
Failure to Power Up 15 15
Failure to Align 14 14
Failure to Read Input Signal 11 11
Display or Visual Feedback Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Loose or Intermittent Connection 10 10
Device Sensing Problem 10 10
Erratic or Intermittent Display 10 10
Device Displays Incorrect Message 8 130
Electrical /Electronic Property Problem 8 8
Smoking 7 7
Signal Artifact/Noise 7 7
Inappropriate/Inadequate Shock/Stimulation 6 6
Appropriate Term/Code Not Available 6 6
Defective Device 6 6
Adverse Event Without Identified Device or Use Problem 6 128
Operating System Becomes Nonfunctional 6 6
Fluid/Blood Leak 6 6
Power Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Mechanical Problem 5 5
Computer Operating System Problem 5 5
Overheating of Device 4 4
Output Problem 4 4
Fire 4 4
Intermittent Loss of Power 4 4
Delayed Program or Algorithm Execution 3 3
Incorrect Measurement 3 3
Failure to Run on Battery 3 3
Noise, Audible 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2175 2297
No Consequences Or Impact To Patient 918 918
No Known Impact Or Consequence To Patient 329 329
Insufficient Information 10 10
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
Urinary Retention 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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