# K071314: Sonoline G20 Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 22, 2007 after 12 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933202 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042833: Sonoline G20 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K040502: Sonoline Ebisu Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 1.
- K946179: Siemens Sonoline 4XX, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Indications for use
The G20TM 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 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/K071314
Methodology: https://510kreport.com/methodology