# K050298: Ipacs Prism-5.0

- Pathway: 510(k) (Traditional)
- Applicant: Realtimeimage, Inc.
- Decided: Feb 28, 2005 after 21 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: 3 generations back to K942120 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030751: Ipacs Prism, Realtimeimage, Inc. (2003) Summary page 1.

## Indications for use
iPACS Prism-5.O TM from Real Time Image Inc. is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. iPACS Prism-5.OTM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K050298
Methodology: https://510kreport.com/methodology