# K973556: Imex Medical Systems, Inc. Imexlab 9000

- Pathway: 510(k) (Traditional)
- Applicant: Imex Medical Systems, Inc.
- Decided: Apr 24, 1998 after 217 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IMEXLAB 9000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use.

Source page: https://510kreport.com/device/K973556
Methodology: https://510kreport.com/methodology