# K981626: Sonoline Elegra Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 27, 1998 after 20 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 K904019 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K950157: Siemens Q64XXX, Siemens Medical Solutions USA, Inc. (1996). Our OCR of the scanned summary read K950517, FDA’s number for Harmony Line PF (Ivoclar North America, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Q64XX, marketed as the SONOLINE Elegra”.
- K961833: Sonoline Elegra with Siescape Feature, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## 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 3-D imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects. 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/K981626
Methodology: https://510kreport.com/methodology