# K221500: ACUSON Sequoia Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 14, 2022 after 22 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: 29 generations back to K935595 (1995). 252 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211859: ACUSON Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.
- K210743: ACUSON Redwood Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K223735: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System (2023), 5 descendants of its own
- K232145: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System (2023), 4 descendants of its own
- K240704: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE  Diagnostic Ultrasound System (2024), 3 descendants of its own
- K242523: ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (2024), 2 descendants of its own
- K251481: ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System (2025), 1 descendant of its own

## 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 supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis. 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. Operating Modes 2D-mode 2D-mode 2D-mode with Harmonics Imaging 2D-mode with Harmonics Imaging for Contrast Agent Imaging 3D/4D Volume Imaging Color flow Doppler Color (velocity) Power (energy) Doppler Pulsed Wave Doppler Pulsed Wave Doppler Tissue Imaging High Pulsed Repetition Frequency Pulsed Wave Doppler Steerable Continuous Wave Doppler for imaging transducers Continuous Wave Doppler for non-imaging transducers M-mode M-mode with Harmonics Imaging Anatomical M-Mode Elastography Strain Imaging Shear Wave Elastography Combined Modes 2D-mode with color 2D-mode with Doppler 2D-mode with color and Doppler 2D-mode with M-mode 2D-mode with M-mode and Color 2D-mode with Elastography

Source page: https://510kreport.com/device/K221500
Methodology: https://510kreport.com/methodology