# K201462: ACUSON Sequoia Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 24, 2020 after 22 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: 27 generations back to K935595 (1995). 213 ancestors in all.
24 later devices descend from it; 3 cite 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)
- K200707: ACUSON Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2020) Summary page 4.
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems, Siemens Healthcare (2017) Summary page 22.

## Most influential descendants
- 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
- 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
- K223735: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (2023), 5 descendants of its own

## Recalls of this device
- Nov 12, 2021 · Class II · Z-0547-2022: Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's conditio

## 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, Adult Cephalic, 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/K201462
Methodology: https://510kreport.com/methodology