Duns Number:608235214
Device Description: IDI,TABLE,VERT.-TILT-ROLL TABLETOP MOVEMENT,SPINAL-IMAGING,ASPECT ISO-DRIVE,120V-230V, TAB IDI,TABLE,VERT.-TILT-ROLL TABLETOP MOVEMENT,SPINAL-IMAGING,ASPECT ISO-DRIVE,120V-230V, TABLETOP WITH FACIAL CUTOUT AND MINI-RAILS,NORTH AMERICA ACC'Y RAILS,#A100-3121
Catalog Number
A100-3121
Brand Name
IMAGE DIAGNOSTICS INC
Version/Model Number
ISO-Drive
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
a0d0db4f-80fb-42e0-ad3e-2e108504f561
Public Version Date
May 27, 2021
Public Version Number
1
DI Record Publish Date
May 19, 2021
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 |