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TPLC
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Device
system, x-ray, angiographic
Regulation Description
Angiographic x-ray system.
Product Code
IZI
Regulation Number
892.1600
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
1
ARTERYFLOW TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
CARL ZEISS MEDITEC INC
SUBSTANTIALLY EQUIVALENT
1
NOVADAQ TECHNOLOGIES ULC (A PART OF STRYKER)
SUBSTANTIALLY EQUIVALENT
1
ONLUME INC.
SUBSTANTIALLY EQUIVALENT
1
SURGVISION GMBH
SUBSTANTIALLY EQUIVALENT
3
SYNAPTIVE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
14
14
2021
29
29
2022
264
264
2023
1198
1198
2024
1317
1317
2025
347
347
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation Failure
1374
1374
Radiation Output Failure
1048
1048
Positioning Failure
407
407
No Display/Image
213
213
Detachment of Device or Device Component
20
20
Unintended System Motion
19
19
Smoking
15
15
Unexpected Shutdown
14
14
No Device Output
12
12
Erratic or Intermittent Display
12
12
Difficult or Delayed Activation
11
11
Failure to Power Up
10
10
Output Problem
8
8
Image Display Error/Artifact
7
7
Insufficient Information
7
7
Display or Visual Feedback Problem
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Device Operational Issue
4
4
Poor Quality Image
4
4
Radiation Underexposure
3
3
Radiation Output Problem
3
3
Break
3
3
Mechanical Jam
3
3
Fire
3
3
Physical Resistance/Sticking
3
3
Device Dislodged or Dislocated
3
3
Unintended Movement
3
3
Computer Software Problem
3
3
Defective Device
3
3
Radiation Overexposure
3
3
Temperature Problem
2
2
Fluid/Blood Leak
2
2
Unexpected/Unintended Radiation Output
2
2
Image Orientation Incorrect
2
2
Appropriate Term/Code Not Available
2
2
Failure to Advance
2
2
No Apparent Adverse Event
2
2
Data Problem
2
2
Difficult or Delayed Positioning
2
2
Key or Button Unresponsive/not Working
2
2
Air/Gas in Device
2
2
Malposition of Device
2
2
Entrapment of Device
2
2
Visual Prompts will not Clear
1
1
Imprecision
1
1
Use of Device Problem
1
1
Gas/Air Leak
1
1
Structural Problem
1
1
Optical Distortion
1
1
Output above Specifications
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3103
3103
Insufficient Information
54
54
No Consequences Or Impact To Patient
9
9
Fall
7
7
No Known Impact Or Consequence To Patient
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Pain
4
4
Laceration(s)
3
3
Crushing Injury
2
2
Radiation Overdose
2
2
Hemorrhage/Bleeding
2
2
Brain Injury
1
1
Skull Fracture
1
1
Bone Fracture(s)
1
1
Head Injury
1
1
Hematoma
1
1
Obstruction/Occlusion
1
1
Hemorrhagic Stroke
1
1
Cardiac Arrest
1
1
Hair Loss
1
1
Paresis
1
1
Myocardial Infarction
1
1
Skin Tears
1
1
Ruptured Aneurysm
1
1
Low Blood Pressure/ Hypotension
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips North America, LLC
II
Mar-13-2020
2
Shimadzu Medical Systems
II
Feb-28-2022
3
Shimadzu Medical Systems
II
Dec-10-2020
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