# K162767: Sentinel BreastScan II System

- Pathway: 510(k) (Special)
- Applicant: First Sense Medical, LLC
- Decided: Jan 9, 2017 after 101 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951806 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032350: Infrared Sciences Breastscan IR System, Infrared Sciences Corp. (2004) Summary page 4.

## Indications for use
The Sentinel BreastScan II System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K162767
Methodology: https://510kreport.com/methodology