DEVICE: CR MD4.0R GENERAL SET (05414904026618)
Device Identifier (DI) Information
CR MD4.0R GENERAL SET
CR MD4.0R GENERAL SET 35X35
In Commercial Distribution
E49ZG
AGFA
CR MD4.0R GENERAL SET 35X35
In Commercial Distribution
E49ZG
AGFA
CR MD4.0R GENERAL SET.35CM X 35CM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44824 | Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray |
A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQB | Solid state x-ray imager (flat panel/digital imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141602 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Width: 35 Centimeter |
Length: 35 Centimeter |
Device Record Status
d4e28e1d-2c97-473e-accf-63988098922d
April 04, 2023
5
September 01, 2016
April 04, 2023
5
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)777-2432
salesinfo@agfa.com
salesinfo@agfa.com