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510(k) K033774

CT-MASS by Medis Medical Imaging Systems BV — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2004
Date Received
December 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
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)
  • K023970 — QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS (January 24, 2003)

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