# K180039: ACUSON P600 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 1, 2018 after 27 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: 23 generations back to K935595 (1995). 217 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141846: Acuson X700 Ultrasound System, Acuson X600 Ultrasound System, Siemens Medical Solutions USA, Inc. (2014) Summary page 21.
- K163635: ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. Ultrasound Group (2017) Summary page 15.
- K163396: ACUSON P500 Ultrasound System, Siemens Medical Solutions USA, Inc. (2017) Summary page 21.
- K170315: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medi Cal Solutions, Inc. (2017) Summary page 21.

## Most influential descendants
- K191922: ACUSON P200 Diagnostic Ultrasound System (2019), 23 descendants of its own
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 descendants of its own
- K201130: ACUSON Juniper Diagnostic Ultrasound System (2020), 14 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

## Indications for use
The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological 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 diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous 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 1s intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease 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/K180039
Methodology: https://510kreport.com/methodology