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510(k) K940172

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS by Medis Medical Imaging Systems, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
January 11, 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

Other clearances by Medis Medical Imaging Systems, Inc.

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  • K073156 — QPLAQUE MR (March 4, 2008)
  • K062386 — QANGIO CT (October 5, 2006)
  • K050703 — QBRAIN (April 21, 2005)
  • K042383 — RSA-CMS (October 20, 2004)
  • K041162 — ORTHO-CMS (July 27, 2004)
  • K040746 — MRA-CMS (June 8, 2004)
  • K033774 — CT-MASS (March 2, 2004)

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