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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
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
DOLPHIN MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
ECHOLIGHT S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ECHOSENS
  SUBSTANTIALLY EQUIVALENT 4
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDGECARE INC.
  SUBSTANTIALLY EQUIVALENT 1
EIELING TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELLEX MEDICAL PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMAGINE SOLUTIONS TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
FCU CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISONO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MAUI IMAGING
  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
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONAVEX, INC
  SUBSTANTIALLY EQUIVALENT 1
SONIC INCYTES
  SUBSTANTIALLY EQUIVALENT 3
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
ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VAVE HEALTH, INC.
  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
2019 537 537
2020 498 620
2021 617 739
2022 511 511
2023 527 527
2024 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1006 1006
No Apparent Adverse Event 397 397
Defective Component 371 371
Battery Problem 334 334
Loss of Power 319 319
Unexpected Shutdown 254 254
Break 232 232
Application Program Freezes, Becomes Nonfunctional 161 161
Contamination /Decontamination Problem 87 87
No Display/Image 69 69
Data Problem 58 58
Image Display Error/Artifact 49 49
Premature Discharge of Battery 44 44
Charging Problem 37 37
Sharp Edges 37 37
Computer Software Problem 29 29
Difficult or Delayed Activation 23 23
Failure to Charge 23 23
Imprecision 18 18
Crack 15 15
Failure to Align 14 14
Failure to Power Up 14 14
Display or Visual Feedback Problem 11 11
Therapeutic or Diagnostic Output Failure 11 11
Failure to Read Input Signal 10 10
Device Sensing Problem 10 10
Erratic or Intermittent Display 10 10
Loose or Intermittent Connection 9 9
Device Displays Incorrect Message 8 130
Electrical /Electronic Property Problem 7 7
Signal Artifact/Noise 7 7
Smoking 6 6
Appropriate Term/Code Not Available 6 6
Operating System Becomes Nonfunctional 6 6
Defective Device 6 6
Fluid/Blood Leak 5 5
Computer Operating System Problem 5 5
Power Problem 5 5
Inappropriate/Inadequate Shock/Stimulation 5 5
Adverse Event Without Identified Device or Use Problem 5 127
Fire 4 4
Intermittent Loss of Power 4 4
Mechanical Problem 4 4
Output Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Noise, Audible 3 3
Overheating of Device 3 3
Failure to Shut Off 3 3
Delayed Program or Algorithm Execution 3 3
Failure to Run on Battery 3 3
Component Missing 3 3
Incorrect Measurement 3 3
Material Split, Cut or Torn 3 3
Connection Problem 2 2
Self-Activation or Keying 2 2
Material Frayed 2 2
Sparking 2 2
Radiofrequency Interference (RFI) 2 2
Device Fell 2 2
Electromagnetic Interference 2 2
Material Protrusion/Extrusion 2 2
Temperature Problem 2 2
Malposition of Device 2 2
Image Orientation Incorrect 1 1
Unable to Obtain Readings 1 1
Grounding Malfunction 1 1
Scratched Material 1 1
Tactile Prompts/Feedback 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Nonstandard Device 1 1
Inadequate User Interface 1 1
Device Emits Odor 1 1
Protective Measures Problem 1 1
Application Program Problem 1 1
Material Separation 1 1
Device Handling Problem 1 1
Peeled/Delaminated 1 1
Leak/Splash 1 1
Device Contamination with Chemical or Other Material 1 1
Physical Resistance/Sticking 1 1
Display Difficult to Read 1 1
Product Quality Problem 1 1
Contamination 1 1
Flare or Flash 1 1
Material Twisted/Bent 1 1
Unintended Application Program Shut Down 1 1
Problem with Software Installation 1 1
Unintended Electrical Shock 1 1
Date/Time-Related Software Problem 1 1
Excessive Cooling 1 1
Measurement System Incompatibility 1 1
Inappropriate Waveform 1 1
Intermittent Continuity 1 1
Difficult or Delayed Positioning 1 1
Explosion 1 1
Activation Failure 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1766 1888
No Consequences Or Impact To Patient 918 918
No Known Impact Or Consequence To Patient 329 329
Insufficient Information 8 8
No Information 6 6
Erythema 5 5
Swelling/ Edema 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pain 3 3
Abrasion 2 2
Hypersensitivity/Allergic reaction 2 2
No Patient Involvement 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Eye Pain 1 1
Burn(s) 1 1
Chest Pain 1 1
Fatigue 1 1
Headache 1 1
Perforation 1 123
Rash 1 1
Vomiting 1 1
Dizziness 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Needle Stick/Puncture 1 1
Aortic Dissection 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Chemical Exposure 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 GE Healthcare, LLC II Jan-24-2022
4 Philips Ultrasound Inc II Sep-17-2021
5 Volcano Corp III Apr-09-2022
6 Volcano Corporation II Dec-12-2019
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