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TPLC
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Device
system, imaging, pulsed echo, ultrasonic
Product Code
IYO
Regulation Number
892.1560
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
75
75
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
978
978
No Apparent Adverse Event
384
384
Defective Component
362
362
Battery Problem
334
334
Loss of Power
319
319
Unexpected Shutdown
252
252
Break
228
228
Application Program Freezes, Becomes Nonfunctional
158
158
Contamination /Decontamination Problem
87
87
No Display/Image
69
69
Data Problem
57
57
Image Display Error/Artifact
49
49
Premature Discharge of Battery
43
43
Charging Problem
37
37
Sharp Edges
37
37
Computer Software Problem
29
29
Failure to Charge
23
23
Difficult or Delayed Activation
23
23
Imprecision
18
18
Crack
15
15
Failure to Power Up
14
14
Failure to Align
14
14
Display or Visual Feedback Problem
11
11
Therapeutic or Diagnostic Output Failure
11
11
Erratic or Intermittent Display
10
10
Failure to Read Input Signal
10
10
Device Sensing Problem
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
Defective Device
6
6
Operating System Becomes Nonfunctional
6
6
Appropriate Term/Code Not Available
6
6
Power Problem
5
5
Adverse Event Without Identified Device or Use Problem
5
127
Computer Operating System Problem
5
5
Inappropriate/Inadequate Shock/Stimulation
5
5
Fluid/Blood Leak
5
5
Fire
4
4
Mechanical Problem
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Output Problem
4
4
Intermittent Loss of Power
4
4
Delayed Program or Algorithm Execution
3
3
Noise, Audible
3
3
Material Split, Cut or Torn
3
3
Overheating of Device
3
3
Incorrect Measurement
3
3
Failure to Run on Battery
3
3
Component Missing
3
3
Failure to Shut Off
3
3
Material Protrusion/Extrusion
2
2
Connection Problem
2
2
Radiofrequency Interference (RFI)
2
2
Sparking
2
2
Malposition of Device
2
2
Self-Activation or Keying
2
2
Electromagnetic Interference
2
2
Material Frayed
2
2
Temperature Problem
2
2
Device Fell
2
2
Unintended Electrical Shock
1
1
Unintended Application Program Shut Down
1
1
Tactile Prompts/Feedback
1
1
Problem with Software Installation
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Physical Resistance/Sticking
1
1
Explosion
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Insufficient Information
1
1
Grounding Malfunction
1
1
Image Orientation Incorrect
1
1
Difficult or Delayed Positioning
1
1
Display Difficult to Read
1
1
Contamination
1
1
Intermittent Continuity
1
1
Material Separation
1
1
Peeled/Delaminated
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Unable to Obtain Readings
1
1
Leak/Splash
1
1
Nonstandard Device
1
1
Device Emits Odor
1
1
Application Program Problem
1
1
Inappropriate Waveform
1
1
Date/Time-Related Software Problem
1
1
Use of Device Problem
1
1
Intermittent Shock/Stimulation
1
1
Activation, Positioning or Separation Problem
1
1
Device Markings/Labelling Problem
1
1
Device Dislodged or Dislocated
1
1
Excessive Cooling
1
1
Material Twisted/Bent
1
1
Measurement System Incompatibility
1
1
Flare or Flash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1722
1844
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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