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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.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.)
  SUBSTANTIALLY EQUIVALENT 2
BIOBOT SURGICAL PTE., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
EDGECARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
EIELING TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
EIELING TECHNOLOGY LIMITED
  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
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
PHILIPS IMAGE GUIDED THERAPY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QT IMAGING HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
QT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
RIVANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONAVEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 3
SONIC INCYTES MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU PEAKSONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
THD SPA
  SUBSTANTIALLY EQUIVALENT 1
ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERDURE IMAGING
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  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
2021 617 739
2022 511 511
2023 527 527
2024 640 640
2025 492 492
2026 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1421 1421
No Apparent Adverse Event 659 659
Defective Component 458 458
Break 279 279
Unexpected Shutdown 277 277
Application Program Freezes, Becomes Nonfunctional 170 170
Sharp Edges 122 122
Contamination /Decontamination Problem 87 87
Data Problem 71 71
Difficult or Delayed Activation 39 39
No Display/Image 36 36
Product Quality Problem 25 25
Computer Software Problem 24 24
Imprecision 21 21
No Device Output 16 16
Crack 16 16
Premature Discharge of Battery 11 11
Overheating of Device 11 11
Loss of Data 10 10
Image Display Error/Artifact 10 10
Contamination 10 10
Battery Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Failure to Charge 7 7
Loose or Intermittent Connection 7 7
Mechanical Problem 7 7
Erratic or Intermittent Display 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Computer Operating System Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Visual Prompts will not Clear 7 7
Failure to Read Input Signal 6 6
Smoking 6 6
Fluid/Blood Leak 5 5
Display or Visual Feedback Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Failure to Power Up 5 5
Fire 4 4
Device Displays Incorrect Message 3 125
Appropriate Term/Code Not Available 3 3
Material Split, Cut or Torn 3 3
Defective Device 3 3
Patient Device Interaction Problem 2 2
Signal Artifact/Noise 2 2
Flare or Flash 2 2
Intermittent Loss of Power 2 2
Communication or Transmission Problem 2 2
Output Problem 2 2
Material Puncture/Hole 2 2
Power Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2876 2998
No Consequences Or Impact To Patient 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Insufficient Information 9 9
Pain 6 6
Cardiac Perforation 5 5
Erythema 4 4
Swelling/ Edema 4 4
Abrasion 2 2
Chest Pain 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Breast Mass 1 1
Electric Shock 1 1
Fatigue 1 1
Dizziness 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Confusion/ Disorientation 1 1
Fever 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
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Civco Medical Instruments Co. Inc. II Apr-01-2026
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
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