# K200644: ACUSON Freestyle Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 10, 2020 after 30 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: 22 generations back to K935595 (1995). 194 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162417: Acuson Freestyle Ultrasound System, Siemens Medi Cal Solutions, Inc. (2016) Summary page 4.

## Most influential descendants
- K202683: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic  Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON  NX3, NX3 Elite Diagnostic Ultrasound System (2020), 6 descendants of its own
- K211726: Acuson SC2000 Diagnostic Ultrasound System (2021), 4 descendants of its own
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (2025), 2 descendants of its own
- K261849: VERAFEYE Imaging Catheter (VF-VIC-002) (2026), 0 descendants of its own
- K260885: VERAFEYE Imaging and Guidance System (VF-VIS-002) (2026), 0 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 performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

Source page: https://510kreport.com/device/K200644
Methodology: https://510kreport.com/methodology