# K150050: ACUSON P500 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 9, 2015 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: 19 generations back to K935595 (1995). 176 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2012) Summary page 4.
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own
- K180039: ACUSON P600 Diagnostic Ultrasound System (2018), 25 descendants of its own
- 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

## Indications for use
The ACUSON P500 ultrasound system is intended for diagnostic ultrasound imaging and fluid flow analysis for the following applications: Fetal, Abdominal, Small Parts, OB/GYN, Pelvic, Cardiovascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and 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.

Source page: https://510kreport.com/device/K150050
Methodology: https://510kreport.com/methodology