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510(k) K843124

Q-SCAN THERMOGRAPHY SYSTEM by Qmax Medical, Inc. — Product Code KXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1984
Date Received
August 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Device Class
Class III
Regulation Number
884.2982
Review Panel
RA
Submission Type

Other clearances for product code KXZ

  • K851034 — NOVATHERM (September 27, 1985)
  • K832731 — BREAST & BODY HEALTH SYSTEM 2000 (January 30, 1984)
  • K813547 — THERMASCAN (March 12, 1982)
  • K781916 — FLEXT-THERM (February 2, 1979)
  • K770986 — FLEXI-THERM FILM (September 12, 1977)
  • K770678 — ELC-THERMO-SYSTEM (May 25, 1977)