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
74 10 000-1
Brand Name
AMRAD Medical
Version/Model Number
Agility Plus
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
K182086
Product Code
OWB
Product Code Name
Interventional Fluoroscopic X-Ray System
Public Device Record Key
48fa523c-1951-4e52-8c60-dd7d0408db48
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 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. | 24 |