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Kodak Directview Cr 800 System, Catalog# 1268622; Kodak Directview Cr 900 System, Catalog# 1170976

by Eastman Kodak Company

510(k) K020635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK020635 Date21 Mar 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0820-2015 FDA Class II initiated 30 Oct 2014 on shared 510(k) K020635

    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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQB
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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