Duns Number:557815751
Device Description: The FireCR Flash can be configured for nearly every clinical application, and is designed The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution.
Catalog Number
CG-401
Brand Name
FireCR Flash
Version/Model Number
FR41
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"
Yes
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
7e5e5839-f84a-4fb7-b0ec-cda36e7774f8
Public Version Date
February 07, 2020
Public Version Number
7
DI Record Publish Date
June 30, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |