# K980423: Sonopsy LA System

- Pathway: 510(k) (Traditional)
- Applicant: Neovision Corp.
- Decided: Aug 7, 1998 after 185 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NeoVision Sonopsy System: named in the summary without a submission number
- (no number) Siemens SONOLINE Prima Digital Ultrasound System: named in the summary without a submission number

## Most influential descendants
- K013886: Avera Model Dei System (Diffractive Energy Imaging System) (2002), 0 descendants of its own

## Indications for use
The intended use of the Sonopsy LA System is as a diagnostic ultrasound imaging system of the human body as follows: Mode of Operation: B-Mode, Clinical Application: Small Organ (breast, thyroid, testes) Abdominal The Sonopsy LA System is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning annular array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes. The system is intended to be used for the real-time ultrasonic guidance of needle aspiration and biopsy procedures of breast lesions. The Sonopsy LA System is indicated for the diagnostic ultrasound B-mode imaging of small organs (breast, thyroid, testes) and the abdomen when used with the hand-held linear array scanhead.

Source page: https://510kreport.com/device/K980423
Methodology: https://510kreport.com/methodology