Kodak Mn-R 2000 Cassette

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K961453 ↗

FDA Product Code

IXA

Device Class

Class II

Regulation

21 CFR Part 892.1850

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 →

• What is the KODAK MN-R 2000 cassette used for?

  The KODAK MN-R 2000 cassette is a radiographic film cassette designed to hold radiographic film during X-ray examinations, facilitating the capture of diagnostic images in medical imaging procedures.

• Is the KODAK MN-R 2000 cassette reusable or single-use?

  The KODAK MN-R 2000 cassette is intended for single-use in radiology settings. It requires proper storage conditions to maintain functionality between uses.

• What is the regulatory classification of the KODAK MN-R 2000 cassette?

  The KODAK MN-R 2000 cassette is classified as Class II under FDA regulation 892.1850. It received FDA clearance on July 25, 1996, with the K number K961453.

• How is the KODAK MN-R 2000 cassette supplied?

  The KODAK MN-R 2000 cassette is supplied by Eastman Kodak Company. The device is manufactured at their facility located at 1669 Lake Ave., Rochester, NY 14652.