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510(k) K970738

KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT by Jamieson Film Co. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1997
Date Received
February 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Jamieson Film Co.

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  • K963334 — JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100 (September 11, 1996)
  • K960043 — KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM (March 27, 1996)
  • K953563 — VANGUARD XR-350 CINEANGIOGRAM PROJECTOR (October 5, 1995)
  • K913241 — JAMIESON JT-CRP CINE FILM PROCESSOR (September 24, 1991)

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