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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
RIVANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 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 640 640
2025 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1350 1350
No Apparent Adverse Event 559 559
Defective Component 442 442
Break 270 270
Unexpected Shutdown 266 266
Application Program Freezes, Becomes Nonfunctional 190 190
Loss of Power 154 154
Battery Problem 134 134
Contamination /Decontamination Problem 87 87
Data Problem 78 78
Sharp Edges 69 69
No Display/Image 45 45
Difficult or Delayed Activation 37 37
Computer Software Problem 26 26
Image Display Error/Artifact 23 23
Imprecision 20 20
Crack 16 16
Contamination 11 11
Premature Discharge of Battery 11 11
Device Sensing Problem 10 10
Loss of Data 9 9
Failure to Read Input Signal 9 9
Overheating of Device 8 8
Display or Visual Feedback Problem 8 8
Loose or Intermittent Connection 8 8
Failure to Charge 8 8
Inappropriate/Inadequate Shock/Stimulation 7 7
Device Displays Incorrect Message 7 129
Therapeutic or Diagnostic Output Failure 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
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
Fluid/Blood Leak 5 5
Smoking 5 5
No Device Output 5 5
Failure to Align 5 5
Visual Prompts will not Clear 4 4
Signal Artifact/Noise 4 4
Appropriate Term/Code Not Available 3 3
Failure to Run on Battery 3 3
Operating System Becomes Nonfunctional 3 3
Material Split, Cut or Torn 3 3
Fire 3 3
Unable to Obtain Readings 2 2
Material Frayed 2 2
Defective Device 2 2
Intermittent Loss of Power 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2527 2649
No Consequences Or Impact To Patient 540 540
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Insufficient Information 10 10
No Known Impact Or Consequence To Patient 7 7
Erythema 5 5
Swelling/ Edema 4 4
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
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
Bacterial Infection 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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