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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
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD
  SUBSTANTIALLY EQUIVALENT 1
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DELPHINUS MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISONO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIGHTMED USA, INC
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC.
  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
QT ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 2
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
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WEIPENG (SUZHOU) MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 362 362
2019 537 537
2020 498 620
2021 617 739
2022 511 511
2023 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 785 785
Battery Problem 356 356
Loss of Power 339 339
No Apparent Adverse Event 299 299
Defective Component 297 297
Unexpected Shutdown 225 225
Break 159 159
Application Program Freezes, Becomes Nonfunctional 132 132
No Display/Image 102 102
Contamination /Decontamination Problem 87 87
Retraction Problem 86 86
Image Display Error/Artifact 72 72
Data Problem 53 53
Premature Discharge of Battery 43 43
Charging Problem 42 42
Erratic or Intermittent Display 29 29
Computer Software Problem 27 27
Sharp Edges 26 26
Failure to Charge 25 25
Difficult or Delayed Activation 23 23
Display or Visual Feedback Problem 20 20
Failure to Align 19 19
Failure to Power Up 19 19
Crack 17 17
Imprecision 16 16
Device Operates Differently Than Expected 14 14
Operating System Becomes Nonfunctional 12 12
Signal Artifact/Noise 12 12
Device Displays Incorrect Message 12 134
Failure to Read Input Signal 11 11
Thermal Decomposition of Device 11 11
Appropriate Term/Code Not Available 11 11
Therapeutic or Diagnostic Output Failure 10 10
Device Sensing Problem 10 10
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 8 130
Power Problem 8 8
Noise, Audible 8 8
Loose or Intermittent Connection 8 8
Electrical /Electronic Property Problem 8 8
Malposition of Device 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Smoking 6 6
Device Stops Intermittently 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Fire 6 6
Loss of Data 6 6
Computer Operating System Problem 5 5
Failure to Shut Off 5 5
Output Problem 4 4
Application Program Problem 4 4
Insufficient Information 4 4
Fluid/Blood Leak 4 4
Sparking 4 4
Component Missing 4 4
Use of Device Problem 3 3
Self-Activation or Keying 3 3
No Device Output 3 3
Overheating of Device 3 3
Failure to Run on Battery 3 3
Electromagnetic Interference 3 3
Intermittent Continuity 3 3
Incorrect Measurement 3 3
Mechanical Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Material Split, Cut or Torn 3 3
Intermittent Loss of Power 3 3
Delayed Program or Algorithm Execution 3 3
Connection Problem 3 3
Calibration Problem 2 2
Device Operational Issue 2 2
Positioning Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Measurement System Incompatibility 2 2
Device Fell 2 2
Temperature Problem 2 2
Explosion 2 2
Material Discolored 2 2
Display Difficult to Read 2 2
Charred 2 2
Image Orientation Incorrect 2 2
Material Frayed 2 2
Product Quality Problem 2 2
Device Emits Odor 2 2
Radiofrequency Interference (RFI) 2 2
Structural Problem 1 1
Microbial Contamination of Device 1 1
Vibration 1 1
Visual Prompts will not Clear 1 1
Intermittent Shock/Stimulation 1 1
Patient-Device Incompatibility 1 1
Date/Time-Related Software Problem 1 1
Material Separation 1 1
Device Inoperable 1 1
Inadequacy of Device Shape and/or Size 1 1
Unable to Obtain Readings 1 1
Nonstandard Device 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1306 1428
No Consequences Or Impact To Patient 1022 1022
No Known Impact Or Consequence To Patient 550 550
No Patient Involvement 22 22
No Information 18 18
Insufficient Information 11 11
Erythema 5 5
Discomfort 4 4
Swelling/ Edema 4 4
Pain 3 3
Complaint, Ill-Defined 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Cardiac Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Partial thickness (Second Degree) Burn 2 2
Vascular Dissection 2 2
No Code Available 1 1
Eye Pain 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Infiltration into Tissue 1 1
Injury 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Aortic Dissection 1 1
Perforation 1 123
Rash 1 1
Shock 1 1
Skin Irritation 1 1
Swelling 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Vomiting 1 1
Dizziness 1 1
Fatigue 1 1
Fistula 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
Abrasion 1 1
Angina 1 1
Burn(s) 1 1
Death 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 ECOLAB INC III Jul-13-2018
4 GE Healthcare, LLC II Jan-24-2022
5 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
6 Parker Laboratories, Inc. II May-09-2018
7 Philips Ultrasound Inc II Sep-17-2021
8 Volcano Corp III Apr-09-2022
9 Volcano Corporation II Dec-12-2019
10 Volcano Corporation II May-17-2018
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