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510(k) K051483

KODAK DIRECTVIEW DR SYSTEM DETECTOR by Eastman Kodak Company — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2005
Date Received
June 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K060055 — KODAK PACS (February 7, 2006)
  • K053347 — KODAK CARESTREAM PACS (January 4, 2006)
  • 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)
  • K040556 — TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY (April 7, 2004)

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