FirstSense Breast Exam

System, Telethermographic (adjunctive Use)

First Sense Medical, LLC

The following data is part of a premarket notification filed by First Sense Medical, Llc with the FDA for Firstsense Breast Exam.

Pre-market Notification Details

• Device ID: K160573
• 510k Number: K160573
• Device Name: FirstSense Breast Exam
• Classification: System, Telethermographic (adjunctive Use)
• Applicant: First Sense Medical, LLC 2001 Centerpoint Parkways, Suite 110 Pontiac, MI 48341
• Contact: Paul G. Angott
• Correspondent: John J. Smith; Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004
• Product Code: LHQ
• CFR Regulation Number: 884.2980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-29
• Decision Date: 2016-06-01
• Summary: summary