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510(k) K030165

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM by Thermatrek — Product Code LHQ

K030165 is an FDA 510(k) premarket notification submitted by Thermatrek for the device "THERMATREK IRIS-IV INFRARED IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 2003. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Thermatrek has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2003
Date Received
January 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

Other clearances by Thermatrek

  • K982112 — THERMATREK IRIS-3 INFRARED IMAGING SYSTEM (August 20, 1998)

Other clearances for product code LHQ

  • K253911 — Derma-2 (May 20, 2026)
  • K232462 — ThermPix Thermovisual Camera (September 14, 2023)
  • K213650 — ThermPix Thermovisual Camera (April 12, 2022)
  • K212965 — Smile-100 System (March 10, 2022)
  • K212412 — IRIS-XP (September 13, 2021)
  • K200999 — Thermidas IR System (ThIR-A615) (January 6, 2021)
  • K181716 — InTouch Thermal Camera (March 25, 2019)
  • K171928 — Med-Hot Thermal Imaging Systems (December 8, 2017)
  • K162767 — Sentinel BreastScan II System (January 9, 2017)
  • K160573 — FirstSense Breast Exam (June 1, 2016)

FDA data resources