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510(k) K073456

T-QUEST SYSTEM by Medx, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
December 10, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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  • 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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