Duns Number:356774109
Device Description: Stationary x-ray system intended for obtaining radiographic images portions of the human b Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Catalog Number
-
Brand Name
OMNERA 500A
Version/Model Number
Precision i5
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
K140683
Product Code
KPR
Product Code Name
System, X-Ray, Stationary
Public Device Record Key
2f0c33db-867d-415d-982f-03874cc50e4d
Public Version Date
April 07, 2022
Public Version Number
1
DI Record Publish Date
March 30, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |