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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
ACCUTOME, INC. DOING BUSINESS AS KEELER USA
  SUBSTANTIALLY EQUIVALENT 1
ASTRASONO TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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
DEEPSIGHT TECHNOLOGY, INC.
  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
SONIC INCYTES MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1453 1453
No Apparent Adverse Event 637 637
Defective Component 470 470
Break 279 279
Unexpected Shutdown 276 276
Application Program Freezes, Becomes Nonfunctional 203 203
Loss of Power 154 154
Battery Problem 134 134
Contamination /Decontamination Problem 87 87
Data Problem 82 82
Sharp Edges 80 80
No Display/Image 46 46
Difficult or Delayed Activation 37 37
Computer Software Problem 26 26
Image Display Error/Artifact 23 23
Imprecision 21 21
Crack 17 17
Contamination 11 11
Premature Discharge of Battery 11 11
Overheating of Device 11 11
No Device Output 10 10
Device Sensing Problem 10 10
Failure to Read Input Signal 9 9
Loss of Data 9 9
Failure to Charge 8 8
Adverse Event Without Identified Device or Use Problem 8 130
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Loose or Intermittent Connection 8 8
Display or Visual Feedback Problem 8 8
Inappropriate/Inadequate Shock/Stimulation 7 7
Therapeutic or Diagnostic Output Failure 7 7
Smoking 7 7
Device Displays Incorrect Message 7 129
Erratic or Intermittent Display 6 6
Mechanical Problem 6 6
Visual Prompts will not Clear 6 6
Failure to Power Up 6 6
Electrical /Electronic Property Problem 5 5
Fire 5 5
Fluid/Blood Leak 5 5
Failure to Align 5 5
Signal Artifact/Noise 4 4
Defective Device 3 3
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 3 3
Operating System Becomes Nonfunctional 3 3
Failure to Run on Battery 3 3
Charging Problem 3 3
Material Protrusion/Extrusion 2 2
Power Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2699 2821
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
Pain 5 5
Swelling/ Edema 4 4
Cardiac Perforation 3 3
Hypersensitivity/Allergic reaction 2 2
Abrasion 2 2
Urinary Retention 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Arrhythmia 1 1
Breast Mass 1 1
Electric Shock 1 1
Fatigue 1 1
Dizziness 1 1
Perforation 1 123
Cramp(s) /Muscle Spasm(s) 1 1
Confusion/ Disorientation 1 1
Burn(s) 1 1
Rash 1 1
Chest Pain 1 1
Micturition Urgency 1 1
Vomiting 1 1
Discomfort 1 1
Anaphylactic Shock 1 1
Stenosis 1 1
Anxiety 1 1
Unspecified Tissue Injury 1 1
Caustic/Chemical Burns 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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