Duns Number:713565195
Device Description: The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recor The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
Catalog Number
-
Brand Name
FCR PRIMA II
Version/Model Number
CR-IR 391RU
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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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
5c0195f3-e29b-4077-b117-d21ed91c284d
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 16, 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 | 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 |