# K243299: ACUSON Redwood Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 15, 2024 after 28 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). 251 ancestors in all.
No later device cites it as a predicate yet.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210743: ACUSON Redwood Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2021) Summary page 6.

## Indications for use
The ACUSON Redwood 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, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Transcranial, and Peripheral Vascular. The system supports the Ultrasound-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: fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial), 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 with Harmonic imaging • Color flow Doppler - Color (velocity) - Power (energy) - Doppler Tissue Imaging • Pulsed Wave Doppler - Pulsed Wave Doppler Tissue Imaging - High Pulsed Repetition Frequency Pulsed Wave Doppler • Continuous Wave Doppler - Steerable Continuous Wave Doppler for phased array transducers - Auxiliary Continuous Wave Doppler for pencil transducers • M-mode - M-mode with Harmonic imaging - Anatomical M-mode • Volume Imaging Combined Modes • 2D-mode with Color • 2D-mode with power • 2D/Doppler • 2D/Doppler with Color • 2D/Doppler with power • 2D/M-mode * 2D/M-mode with color * 2D/Anatomical M-mode

Source page: https://510kreport.com/device/K243299
Methodology: https://510kreport.com/methodology