# K212887: RTapp

- Pathway: 510(k) (Traditional)
- Applicant: Segana, Inc.
- Decided: Nov 10, 2021 after 61 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: 14 generations back to K954874 (1996). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191610: RTapp, Segana, LLC (2019) Summary page 4.

## Indications for use
RTapp™ is a stand-alone software that provides a means for comparison of imaging data that is DICOM compliant. It allows the registration and display of medical images as an aid during use by radiation oncology.

Source page: https://510kreport.com/device/K212887
Methodology: https://510kreport.com/methodology