Duns Number:687967554
Device Description: The GC80 Series Digital X-ray imaging System is intended for use in generating radiographi The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Catalog Number
-
Brand Name
NA
Version/Model Number
GC80
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143029
Product Code
KPR
Product Code Name
System, X-Ray, Stationary
Public Device Record Key
dfeaafd9-c0a3-4168-9056-7374089b3a3b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 31, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |