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510(k) K160573

FirstSense Breast Exam by First Sense Medical, LLC — Product Code LHQ

K160573 is an FDA 510(k) premarket notification submitted by First Sense Medical, LLC for the device "FirstSense Breast Exam". The FDA issued a decision of Substantially Equivalent on June 1, 2016. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. First Sense Medical, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
February 29, 2016
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 First Sense Medical, LLC

  • K162767 — Sentinel BreastScan II System (January 9, 2017)

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)
  • K150457 — AlfaSight 9000 Thermographic System (April 10, 2015)

FDA data resources