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510(k) K920031

KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE by Eastman Kodak Company — Product Code JAC

K920031 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE". The FDA issued a decision of Substantially Equivalent on February 12, 1992. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1992
Date Received
January 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
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 JAC

  • K942883 — DIGITAL I.D. CAMERA (September 30, 1994)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • K932357 — FUJI EC ID CAMERA (July 26, 1993)
  • K925892 — SOLSTICE XRAY RING MARKER PAD (May 18, 1993)
  • K923533 — ADMARK (March 4, 1993)
  • K926404 — KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (March 4, 1993)
  • K925332 — BENNETT X-RAY ID PLUS (November 27, 1992)
  • K924345 — RADIOGRAPHIC FILM MARKETING SYSTEM (November 27, 1992)
  • K915088 — KODAK MIN-R IDENTIFICATION CAMERA (December 2, 1991)
  • K913478 — RADIOGRAPHIC FILM MARKING SYSTEM (October 15, 1991)

FDA data resources