# K071602: Imagic V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Ashva Technologies, Pvt., Ltd.
- Decided: Jul 23, 2007 after 42 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
Longest line of descent: 5 generations back to K010259 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062062: Voyager Pacs System, Voyager Imaging (2006) Summary page 1.

## Indications for use
iMagic v2.OTM device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware. iMagic v2.OTM receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0TM does not use lossy (irreversible) compression during image handling, manipulation, or storage. Only DICOM, for presentation, images will be captured for display and diagnosis. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic 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/K071602
Methodology: https://510kreport.com/methodology