Duns Number:608235214
Device Description: IDI,TABLE,VERT.-TILT-ROLL-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT IDI,TABLE,VERT.-TILT-ROLL-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT ISR,120V-230V, TABLETOP WITH MINI-RAILS,METRIC ACC'Y RAILS,#A100-2834
Catalog Number
A100-2834
Brand Name
IMAGE DIAGNOSTICS INC
Version/Model Number
ISR G3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXR
Product Code Name
Table, Radiographic, Tilting
Public Device Record Key
a854fe65-f52d-433d-8423-8a6de73f0cf9
Public Version Date
November 16, 2021
Public Version Number
2
DI Record Publish Date
March 09, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |