# K012369: Basic, Models Basic 1, Basic 2, and Basic 3

- Pathway: 510(k) (Traditional)
- Applicant: Atys Medical
- Decided: Aug 10, 2001 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K872517 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872517: TL 400 Totalab Vascular Diagnostic System, D. E. Hokanson, Inc. (1987) Summary page 1.
- K973644: Flostat Vascular Lab, Biomedix, Inc. (1997) Summary page 1.
- K973562: Imex Medical Systems, Inc. Imexlab 9100, Imex Medical Systems, Inc. (1998) Summary page 1.

## Indications for use
The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous). The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications. The BASIC is not intended for home use. The BASIC is not intended for use on non-intact skin or eyes.

Source page: https://510kreport.com/device/K012369
Methodology: https://510kreport.com/methodology