# K961833: Sonoline Elegra with Siescape Feature

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 29, 1996 after 169 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 K945072 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945072: Siemens Q4000, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K981626: Sonoline Elegra Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above, which are identical to those included in the original submission for the Elegra. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard B-mode imaging ultrasound systems.

Source page: https://510kreport.com/device/K961833
Methodology: https://510kreport.com/methodology