DEVICE: CR MD4.0T PLATE (05414904027998)

Device Identifier (DI) Information

CR MD4.0T PLATE
CR MD4.0T PLATE 18X24
In Commercial Distribution
E4VCK
AGFA
05414904027998
GS1

1
374444883 *Terms of Use
CR MD4.0T PLATE 18CM X 24CM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQB Solid state x-ray imager (flat panel/digital imager)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062223 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Width: 24 Centimeter
Length: 18 Centimeter
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Device Record Status

f7fe71a6-f782-4125-9187-291536d217b9
April 04, 2023
5
September 01, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(877)777-2432
salesinfo@agfa.com
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