Kodak Ektascan

• • Terminated Z-0820-2015 FDA Class II ·initiated 30 Oct 2014 ·via K923554, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K923554 ↗

FDA Product Code

IXW

Device Class

Class II

Regulation

21 CFR Part 892.1900

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Kodak Surecell Hcg Urine Test, Modification

  Class II

  FDA 510(k) K936287 Active Cleared 8 Apr 1994

• Kodak Ektaspeed Dental X-Ray Film

  Class I

  FDA 510(k) K800901 Active Cleared 20 May 1980

• Kodak X-Omat 3000 Ra Processor

  Class II

  FDA 510(k) K951396 Active Cleared 15 May 1995

• Kodak X-Omat M43A, M43, & Clinic 1 Processors

  Class II

  FDA 510(k) K934350 Active Cleared 21 Mar 1994

• Amerlite Prolactin-30 Assay

  Class I

  FDA 510(k) K922170 Active Cleared 2 Sep 1992

• Trophypan C with Orthoimaging/Omsimaging Accessory

  Class II

  FDA 510(k) K040556 Active Cleared 7 Apr 2004

See all devices from Eastman Kodak Company →