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510(k) K053347

KODAK CARESTREAM PACS by Eastman Kodak Company — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2006
Date Received
December 2, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
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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