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510(k) K925997

KODAK EKTASCAN SP CASSETTE by Eastman Kodak Company — Product Code IXJ

K925997 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTASCAN SP CASSETTE". The FDA issued a decision of Substantially Equivalent on December 17, 1992. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1992
Date Received
November 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
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 IXJ

  • K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID (June 13, 1997)
  • K963893 — FIBRE INTERSPACED X-RAY GRID (November 7, 1996)
  • K962338 — RADIOGRAPHIC GRID (July 3, 1996)
  • K954294 — HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (February 2, 1996)
  • K945697 — SK S-RAY GRIDS (January 31, 1995)
  • K945327 — JPI X-RAY GRID (January 20, 1995)
  • K941626 — GRIDGIL (May 13, 1994)
  • K940309 — X-RAY GRID (RADIOLOGICAL GRID) (April 22, 1994)
  • K926445 — SOYEE ALUMINUM INTERSPACED X-RAY GRID (April 7, 1993)
  • K926261 — JPI ALUMINUM INTERSPACED X-RAY GRID (March 18, 1993)

FDA data resources