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510(k) K082581

C-QUEST by Medx, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2008
Date Received
September 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Medx, Inc.

  • K073456 — T-QUEST SYSTEM (December 20, 2007)
  • K041840 — MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (August 20, 2004)
  • K012953 — GIOTTO IMAGE (November 30, 2001)
  • K993893 — MEDX INTECAM INTERFACE (February 10, 2000)
  • K911666 — MEDX MACHINE (July 3, 1991)
  • K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE (January 2, 1990)
  • K895236 — MEDX REHABILITATION MACHINE (September 14, 1989)
  • K884661 — D-SCOPE III (April 12, 1989)
  • K872127 — D-SCOPE II AND D-SCOPE IIC (June 18, 1987)
  • K870703 — SKAN D-SCOPE (February 26, 1987)

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