Duns Number:440069847
Device Description: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance an This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.
Catalog Number
95 02 000
Brand Name
FUJIFILM Healthcare Americas Corporation
Version/Model Number
Persona CS
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
K211777
Product Code
OWB
Product Code Name
Interventional Fluoroscopic X-Ray System
Public Device Record Key
ebf02ed2-082b-41ac-a47a-5ad99a3a29a9
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |