# K120718: Instapacs/Instarispacs

- Pathway: 510(k) (Special)
- Applicant: Meddiff Technologies Pvt., Ltd.
- Decided: Apr 19, 2012 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: 6 generations back to K945188 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080334: Instarad, Medsphere Technologies Pvt, Ltd. (2008) Summary page 1.

## Indications for use
InstaPACSTM/InstaRISPACS TM is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RE 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. InstaPACSTM/instaRISPACS TM 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/K120718
Methodology: https://510kreport.com/methodology