# K222198: Exo Iris  (El2001)

- Pathway: 510(k) (Traditional)
- Applicant: Exo Imaging, Inc.
- Decided: Nov 9, 2022 after 110 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: 25 generations back to K935595 (1995). 277 ancestors in all.
No later device cites it as a predicate yet.
6 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211527: Exo Iris, Exo Imaging, Inc. (2021) Summary page 4.

## Indications for use
Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include: B-Mode, B-Mode + Color Doppler, B-Mode + M-Mode.

Source page: https://510kreport.com/device/K222198
Methodology: https://510kreport.com/methodology