# K201296: i-Rapha Solution

- Pathway: 510(k) (Traditional)
- Applicant: Irm, Inc.
- Decided: Jul 9, 2020 after 55 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: 7 generations back to K954678 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152977: DG Pacs, Dicom Grid, Inc. (2016) Summary page 4.

## Indications for use
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic. i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.

Source page: https://510kreport.com/device/K201296
Methodology: https://510kreport.com/methodology