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DIRECTVIEW CR Mammography Cassette with EHR-M Screen

by Carestream Health, Inc. 10 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Jun 2026. What this means

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number40889971290386 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0820-2015 FDA Class II initiated 30 Oct 2014 on shared PMA P080018

    Reduced mammographic image quality when attempting to print true size multi-format images

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Digital imaging cassette/storage phosphor screen, mammographic
Model / Ref / Catalog
DIRECTVIEW CR Mammography Cassette with EHR-M Screen, 1290386
Primary DI / UDI-DI
40889971290386
PMA Number
FDA Product Code
MUE
GMDN Term
Digital imaging cassette/storage phosphor screen, mammographic
Device Class
Class II
Regulation Number
892.1715
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P080018)

Show all (12)

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No