Duns Number:713565195
Device Description: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdo The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
Catalog Number
47410-05929
Brand Name
FUJI IMAGING PLATE
Version/Model Number
IP-6 ST 25.2X30.3CM 1 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
900775a1-cb35-4c19-ad80-20e490316e40
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
14547410059295
Quantity per Package
20
Contains DI Package
04547410059298
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 |