# K981528: Sonoline Elegra Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 28, 1998 after 182 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: 2 generations back to K935595 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973767: Harmonic Imaging with Contrast, Acuson Corp. (1997) Summary page 1.
- K945072: Siemens Q4000, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K992046: Sonoline 7XX Diagnostic Ultrasound System (1999), 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, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of contrast agent imaging will not add any new applications or intended uses. 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/K981528
Methodology: https://510kreport.com/methodology