# K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Dec 22, 2008 after 244 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 59 ancestors in all.
325 later devices descend from it; 6 cite it directly.
0 of 385 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- (no number) U-Systems ultrasound system: named in the summary without a submission number

## Most influential descendants
- K111674: Acuson (2011), 223 descendants of its own
- K121138: Acuson S3000 Diagnostic Ultrasound System (2012), 198 descendants of its own
- K112596: Acuson S2000 Diagnostic Ultrasound System (2011), 192 descendants of its own
- K130739: Acuson S2000 and S3000 Diagnostic Ultrasound Systems (2013), 177 descendants of its own
- K131164: Acuson (2013), 124 descendants of its own

## Recalls of this device
- Jan 12, 2015 · Class II · Z-1063-2015: There is a low probability the scanner arm will become completely detached from the scanner column.
- Jan 18, 2013 · Class II · Z-0930-2013: On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
- Mar 28, 2011 · Not classified · Z-2150-2011: The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.

## Indications for use
The Modified $2000, the $2000 ABVS Ultrasound System, is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system supports the transducers listed in the Ultrasound Indications for Use tables, including the 14LSBV for B-mode imaging of a patient’s breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography. The system also provides for the measurement of anatomical structures and analysis as provided in the original $2000 Ultrasound System, which provides information that is used by medical health care professionals for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K081148
Methodology: https://510kreport.com/methodology