Duns Number:428658934
Device Description: The Opera Swing is an x-ray diagnostic system and is indicated for performing general radi The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.
Catalog Number
-
Brand Name
OPERA SWING
Version/Model Number
X-RAY R&F REMOTE SYSTEM OPERA SWING
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
K140380
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
bbb79bb7-7e27-465a-bda9-718f1eec4beb
Public Version Date
April 10, 2019
Public Version Number
4
DI Record Publish Date
September 22, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |