# K150457: AlfaSight 9000 Thermographic System

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Thermodiagnostics, Inc.
- Decided: Apr 10, 2015 after 49 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: 1 generation back to K971956 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971956: CRT2000 Thermographic System, Werner Eidam Medizin-Technologie GmbH (1997) Summary page 4.

## Most influential descendants
- K181643: SmartBag (SmartPouch) (2018), 0 descendants of its own

## Indications for use
The AlfaSight 9000 is intended for the adjunct diagnosis of: 1) abnormalities of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions. The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.

Source page: https://510kreport.com/device/K150457
Methodology: https://510kreport.com/methodology