# K072090: Siemens Diagnostic Ultrasound Systems

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decided: Sep 14, 2007 after 46 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: 10 generations back to K935595 (1995). 47 ancestors in all.
189 later devices descend from it; 5 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061980: Siemens Acuson X500 Ultrasound System, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K071036: Modification to Acuson X300 Ultrasound System, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.
- K052410: Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.

## Most influential descendants
- K091286: Syngo US Workplace (2009), 95 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own

## Indications for use
The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K072090
Methodology: https://510kreport.com/methodology