Home / 510(k) Clearances / K050239

510(k) K050239

EMD THERMOGRAPHY SYSTEM by Em Diagnostics, Inc. — Product Code LHQ

K050239 is an FDA 510(k) premarket notification submitted by Em Diagnostics, Inc. for the device "EMD THERMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
February 2, 2005
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 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