# K201130: ACUSON Juniper Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 26, 2020 after 28 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K935595 (1995). 218 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180039: ACUSON P600 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.

## Most influential descendants
- 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
- K221190: ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System (2022), 4 descendants of its own
- K211726: Acuson SC2000 Diagnostic Ultrasound System (2021), 4 descendants of its own
- K230207: ACUSON Juniper Diagnostic Ultrasound  System, ACUSON Juniper Select Diagnostic Ultrasound System (2023), 3 descendants of its own
- K242893: VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (2025), 2 descendants of its own

## Recalls of this device
- Aug 15, 2024 · Class II · Z-3215-2024: 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-1599-2024: 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
- Jan 19, 2022 · Class II · Z-0748-2022: The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as 
- Jul 12, 2021 · Class II · Z-2471-2021: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

## Indications for use
The ACUSON Juniper 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: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in vitro fertilization (IVF), chorionic villus sampling (CVS), and percutancous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Discase and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

Source page: https://510kreport.com/device/K201130
Methodology: https://510kreport.com/methodology