# K113082: Sonovision

- Pathway: 510(k) (Traditional)
- Applicant: Peridot Technologies Ny, Inc.
- Decided: Mar 8, 2012 after 142 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Sonovision is intended for use by obstetricians, gynecologists, radiologists, ultrasound technicians and cardiologists. The system is designed for use in hospitals, medical imaging labs and medical offices. Sonovision works as Workstation Software for Ultrasound Image Acquisition, Reviewing, Patient studies data management, Reporting, Sending Studies to PACS Server or Making DICOM COIDVO. Lossy compressed mamnmographic images and digitized film screen images must not be reviewed for primary image interpretation. Mamnmographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K113082
Methodology: https://510kreport.com/methodology