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510(k) K944952

ANGIOGRAPHIC SYSTEM by Acoma Medical Imaging, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1995
Date Received
October 7, 1994
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

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  • K902637 — FUTURUS 2001 X-RAY GENERATOR (August 3, 1990)
  • K900562 — TRANS X 100 CHEST FILM CHANGER (April 10, 1990)

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