# K162417: Acuson Freestyle Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Sep 28, 2016 after 29 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: 21 generations back to K935595 (1995). 193 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100598: Penrith Elettra Ultrasound System, Penrith Corporation (2010) Summary page 9.
- K152369: ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System, Siemens Medical Solutions USA, Inc. Ultrasound Group (2015) Summary page 9.

## Most influential descendants
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own
- K191922: ACUSON P200 Diagnostic Ultrasound System (2019), 23 descendants of its own
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 descendants of its own
- K201130: ACUSON Juniper Diagnostic Ultrasound System (2020), 14 descendants of its own

## Indications for use
The ACUSON Freestyle™ Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Source page: https://510kreport.com/device/K162417
Methodology: https://510kreport.com/methodology