# K113259: Notouch Breastscan

- Pathway: 510(k) (Traditional)
- Applicant: Ue Lifesciences, Inc.
- Decided: Feb 10, 2012 after 98 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Breastscan IR: named in the summary without a submission number

## Indications for use
The NoTouch BreastScan 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 an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.

Source page: https://510kreport.com/device/K113259
Methodology: https://510kreport.com/methodology