# K990416: Omnicorder Bioscan System

- Pathway: 510(k) (Traditional)
- Applicant: Omnicorder Technologies, Inc.
- Decided: Dec 23, 1999 after 316 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: 2 generations back to K951806 (1995). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982327: Inframetrics Infracam-Med, Inframetrics, Inc. (1998) Summary page 3.
- K897191: Bsi Model Tip, Bales Scientific, Inc. (1990) Summary page 3.
- K823041: Jeol Model #JTG-500M, Jeol (1982) Summary page 3.
- K812799: DCATS, Dorex, Inc. (1981) Summary page 3.

## Most influential descendants
- K032350: Infrared Sciences Breastscan IR System (2004), 2 descendants of its own
- K162767: Sentinel BreastScan II System (2017), 0 descendants of its own
- K160573: FirstSense Breast Exam (2016), 0 descendants of its own

## Indications for use
The OmniCorder BioScan 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, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting the 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/K990416
Methodology: https://510kreport.com/methodology