DEVICE: DIRECTVIEW CR Mammography Cassette with HR Screen (60889971650511)
Device Identifier (DI) Information
DIRECTVIEW CR Mammography Cassette with HR Screen
DIRECTVIEW CR Mammography Cassette with HR Screen
Not in Commercial Distribution
1650514
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Mammography Cassette with HR Screen
Not in Commercial Distribution
1650514
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassett with HR Scrn 24x30
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44825 | Digital imaging cassette/storage phosphor screen, mammographic |
A combination device for mammography 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 mammography x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the mammography 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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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MUE | Full field digital,system,x-ray,mammographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P080018 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
567037f3-0da4-4fdd-b7d1-f7278e005442
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
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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
[?]
No Customer Contact currently defined