# K072786: Acuson S2000 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 13, 2007 after 43 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935595 (1995). 58 ancestors in all.
800 later devices descend from it; 16 cite it directly.
2 of 859 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063803: Acuson Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.
- K063085: Modification to Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System, General Electric Co. (2003) Summary page 1.

## Most influential descendants
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K091970: Aixplorer Ultrasound System (2009), 528 descendants of its own
- K102041: Aixplorer (2010), 527 descendants of its own

## Indications for use
The S 2 0 0 0 TM ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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/K072786
Methodology: https://510kreport.com/methodology