# K180697: Pseudo-Patient

- Pathway: 510(k) (Traditional)
- Applicant: Rtsafe, Inc.
- Decided: Jul 10, 2018 after 116 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K914698 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151426: ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+, Scandidos AB (2016) Summary page 4.

## Indications for use
The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.

Source page: https://510kreport.com/device/K180697
Methodology: https://510kreport.com/methodology