# K191922: ACUSON P200 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 15, 2019 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: 25 generations back to K935595 (1995). 246 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180067: ACUSON X800 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.
- K183575: ACUSON S3000, S2000 Diagnostic Ultrasound System, Siemens Healthineers (2019) Summary page 8.
- K180039: ACUSON P600 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2018) Summary page 4.

## Most influential descendants
- K210743: ACUSON Redwood Diagnostic Ultrasound System (2021), 15 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
- 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

## Indications for use
The ACUSON P200 ultrasound imaging system is intended 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, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, 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.

Source page: https://510kreport.com/device/K191922
Methodology: https://510kreport.com/methodology