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510(k) K961453

KODAK MN-R 2000 CASSETTE by Eastman Kodak Company — Product Code IXA

K961453 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK MN-R 2000 CASSETTE". The FDA issued a decision of Substantially Equivalent on July 25, 1996. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
April 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Eastman Kodak Company

  • K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (March 31, 2006)
  • K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE (March 16, 2006)
  • K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM (February 8, 2006)
  • K060055 — KODAK PACS (February 7, 2006)
  • K053347 — KODAK CARESTREAM PACS (January 4, 2006)
  • K051483 — KODAK DIRECTVIEW DR SYSTEM DETECTOR (June 21, 2005)
  • K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (June 1, 2005)
  • K042159 — KODAK COLOR MEDICAL IMAGER 1000 (September 24, 2004)
  • K042158 — KODAK MEDICAL IMAGER 300 (September 24, 2004)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (August 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)

FDA data resources