Duns Number:713565195
Device Description: The DRYPIX Lite is a printer that prints onto film images received via the DICOM network f The DRYPIX Lite is a printer that prints onto film images received via the DICOM network from modalities such as FCR image readers and CT or MRI scanners. The DRYPIX Lite can also be used to print onto film images from modalities or image processors that are not on the DICOM network.
Catalog Number
-
Brand Name
DRYPIX Lite
Version/Model Number
DRYPIX 2000
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
LMC
Product Code Name
Camera, multi format, radiological
Public Device Record Key
e18cd0f0-143d-4ff0-a6b6-a8f954e1b21f
Public Version Date
December 04, 2020
Public Version Number
3
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 |