# K080334: Instarad

- Pathway: 510(k) (Traditional)
- Applicant: Medsphere Technologies Pvt, Ltd.
- Decided: Feb 21, 2008 after 14 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 K945188 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062490: Visage Pacs/CS, Release Version 4.1, Mercury Computer Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K133357: Charruapacs System (2013), 0 descendants of its own
- K120718: Instapacs/Instarispacs (2012), 0 descendants of its own

## Indications for use
InstaRad T M is a software device (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad M T can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records. 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/K080334
Methodology: https://510kreport.com/methodology