Duns Number:069190036
Device Description: The Radlink CR Pro system is a computed radiography system designed for all primary diagno The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist.
Catalog Number
-
Brand Name
Radlink CR Pro 2200
Version/Model Number
CR201-1
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)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052938
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
559d4a89-8907-449b-a1e6-32dd0b91463c
Public Version Date
April 23, 2019
Public Version Number
6
DI Record Publish Date
September 21, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |