Duns Number:713565195
Device Description: Inserting the Fuji Imaging Plate ST-VI 15cmx30cm into the adapter to insert it into 35cmx4 Inserting the Fuji Imaging Plate ST-VI 15cmx30cm into the adapter to insert it into 35cmx43cm cassette makes image reading in the Fuji Computed Radiography possible.
Catalog Number
47410-22210
Brand Name
15X30 IP ADAPTER
Version/Model Number
IR ADAPTER FOR IP 15X30CM E
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
-
Product Code
MQB
Product Code Name
Solid state x-ray imager (flat panel/digital imager)
Public Device Record Key
9d3e97df-75d3-4c7b-b611-787c66671dde
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
14547410222101
Quantity per Package
10
Contains DI Package
04547410222104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |