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510(k) K051258

KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 by Eastman Kodak Company — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2005
Date Received
May 16, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • 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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