# K973562: Imex Medical Systems, Inc. Imexlab 9100

- Pathway: 510(k) (Traditional)
- Applicant: Imex Medical Systems, Inc.
- Decided: Apr 15, 1998 after 208 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.
50 later devices descend from it; 3 cite it directly.
0 of 51 devices 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.

## Most influential descendants
- K013434: VP-2000/1000 (2002), 46 descendants of its own
- K082357: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200). (2008), 27 descendants of its own
- K151869: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2015), 15 descendants of its own
- K153077: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2016), 12 descendants of its own
- K080670: Modification to Sphygmocor Cardiovascular Management System (2008), 8 descendants of its own

## Indications for use
The IMEXLAB 9100 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/K973562
Methodology: https://510kreport.com/methodology