# K193257: ACUSON Sequoia Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 31, 2020 after 66 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 211 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 238 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180067: ACUSON X800 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems, Siemens Healthcare (2017) Summary page 18.

## Most influential descendants
- K200707: ACUSON Sequoia Diagnostic Ultrasound System (2020), 25 descendants of its own
- K201462: ACUSON Sequoia Diagnostic Ultrasound System (2020), 24 descendants of its own
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 descendants of its own
- K211859: ACUSON Sequoia Diagnostic Ultrasound System (2021), 7 descendants of its own
- K221500: ACUSON Sequoia Diagnostic Ultrasound System (2022), 6 descendants of its own

## Recalls of this device
- Feb 4, 2021 · Class II · Z-1330-2021: The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may infl

## Indications for use
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K193257
Methodology: https://510kreport.com/methodology