# K210743: ACUSON Redwood Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 1, 2021 after 20 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K935595 (1995). 250 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191922: ACUSON P200 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2019) Summary page 5.
- K201462: ACUSON Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems, Siemens Healthcare (2017) Summary page 5.

## Most influential descendants
- K221500: ACUSON Sequoia Diagnostic Ultrasound System (2022), 6 descendants of its own
- 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
- K221190: ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System (2022), 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

## Recalls of this device
- Aug 15, 2024 · Class II · Z-3216-2024: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect
- Feb 23, 2024 · Class II · Z-1600-2024: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into
- Jul 13, 2023 · Class II · Z-2582-2023: If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results whe

## 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/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The systems also provide the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (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. Mode of operation: 2D-mode 2D-mode with Harmonics 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 Harmonics 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/K210743
Methodology: https://510kreport.com/methodology