# K981153: Osiris

- Pathway: 510(k) (Traditional)
- Applicant: Huestis Medical
- Decided: Mar 17, 1999 after 352 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
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052682: Alignrt (2006), 18 descendants of its own
- K072171: Gatect-RT (2007), 12 descendants of its own
- K123371: Alignrt Plus (2013), 8 descendants of its own
- K181218: AlignRT Plus (2018), 7 descendants of its own
- K193431: AlignRT Plus (2020), 6 descendants of its own

## Indications for use
The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours. The professional groups using the OSIRIS system can include Medical staff, radiographers, technicians and medical physicists — all of whom are professionally employed within a radiotherapy department and are specialists in the use of surface contours for radiotherapy treatments. The main users are those who use Radiotherapy Simulators for treatment simulation and verification, and the staff who treat patients on linear accelerator therapy machines. The same groups of staff will use the surface contours for isodose production, where appropriate, and define the setup data and any additional measurements required, according to the QA programs running in that department. Typical application is in the measurement and calculation of missing tissue compensator filters.

Source page: https://510kreport.com/device/K981153
Methodology: https://510kreport.com/methodology