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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
Regulation Description Ultrasonic pulsed echo imaging system.
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
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 4
EDGECARE INC.
  SUBSTANTIALLY EQUIVALENT 1
EIELING TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EIELING TECHNOLOGY LIMITED
  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
MAUI IMAGING
  SUBSTANTIALLY EQUIVALENT 1
MCUBE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
METRITRACK, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAVIFUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 4
SONIVATE MEDICAL INC
  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
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
2020 498 620
2021 617 739
2022 511 511
2023 527 527
2024 641 641
2025 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1269 1269
No Apparent Adverse Event 518 518
Defective Component 424 424
Break 266 266
Unexpected Shutdown 259 259
Application Program Freezes, Becomes Nonfunctional 183 183
Loss of Power 154 154
Battery Problem 134 134
Contamination /Decontamination Problem 87 87
Data Problem 74 74
Sharp Edges 60 60
No Display/Image 44 44
Difficult or Delayed Activation 30 30
Computer Software Problem 25 25
Image Display Error/Artifact 23 23
Imprecision 20 20
Crack 16 16
Premature Discharge of Battery 11 11
Device Sensing Problem 10 10
Failure to Read Input Signal 9 9
Loose or Intermittent Connection 8 8
Failure to Charge 7 7
Device Displays Incorrect Message 7 129
Overheating of Device 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Therapeutic or Diagnostic Output Failure 7 7
Fluid/Blood Leak 6 6
Display or Visual Feedback Problem 6 6
Mechanical Problem 6 6
Erratic or Intermittent Display 6 6
Adverse Event Without Identified Device or Use Problem 6 128
Failure to Power Up 6 6
Electrical /Electronic Property Problem 5 5
Failure to Align 5 5
Smoking 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Signal Artifact/Noise 4 4
Failure to Run on Battery 3 3
Operating System Becomes Nonfunctional 3 3
Material Split, Cut or Torn 3 3
Fire 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 2 2
No Device Output 2 2
Visual Prompts will not Clear 2 2
Intermittent Loss of Power 2 2
Material Puncture/Hole 2 2
Material Frayed 2 2
Charging Problem 2 2
Computer Operating System Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2389 2511
No Consequences Or Impact To Patient 540 540
Insufficient Information 10 10
No Known Impact Or Consequence To Patient 7 7
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
Cardiac Perforation 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Electric Shock 1 1
Fatigue 1 1
Dizziness 1 1
Perforation 1 123
Chemical Exposure 1 1
Confusion/ Disorientation 1 1
Burn(s) 1 1
Rash 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
Eye Pain 1 1
Urinary Tract Infection 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Civco Medical Instruments Co. Inc. II Dec-20-2021
2 GE Healthcare, LLC II Jan-24-2022
3 Philips Ultrasound Inc II Sep-17-2021
4 Volcano Corp III Apr-09-2022
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