# K962882: Sonoline Versa Pro Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 24, 1997 after 274 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: 1 generation back to K924204 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945773: Siemens Sonoline Versa, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K924204: New Ultrasound Imaging System & Transducers, Tetra Corp. (1993) Summary page 1.

## Indications for use
The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic 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/K962882
Methodology: https://510kreport.com/methodology