Duns Number:793169512
Device Description: DRX-REVOLUTION W/TOSHIBA TUBE&CSH GEN
Catalog Number
8612533
Brand Name
DRX-Revolution Mobile X-ray System
Version/Model Number
DRX-Revolution Mobile X-ray System
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 02, 2020
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
K120062
Product Code
IZL
Product Code Name
System, x-ray, mobile
Public Device Record Key
a5bcb4a4-fc7d-4d90-99be-136636a54a26
Public Version Date
June 03, 2020
Public Version Number
2
DI Record Publish Date
January 06, 2019
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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |