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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
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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