Duns Number:313217003
Device Description: AI-Rad Companion Engine product label
Catalog Number
-
Brand Name
AI-Rad Companion Engine
Version/Model Number
11294424
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193294
Product Code
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
5639b706-0b20-41af-8c59-2d388cf5efc7
Public Version Date
November 17, 2021
Public Version Number
3
DI Record Publish Date
February 03, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 478 |
| 3 | A medical device with high risk that requires premarket approval | 1 |