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510(k) K023970

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS by Medis Medical Imaging Systems BV — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
November 29, 2002
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 BV

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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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