# K222803: Oncospace

- Pathway: 510(k) (Traditional)
- Applicant: Oncospace, Inc.
- Decided: Feb 2, 2023 after 139 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 8 generations back to K920879 (1992). 18 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202284: Oncospace, Oncospace, Inc. (2021) Summary page 4.

## Most influential descendants
- K253050: RadOncAI (2026), 0 descendants of its own
- K250064: Dose+ (1.0) (2025), 0 descendants of its own
- K242748: Oncospace (2025), 0 descendants of its own

## Indications for use
Oncospace is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the prostate, head, and neck regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). This device is for prescription use by order of a physician.

Source page: https://510kreport.com/device/K222803
Methodology: https://510kreport.com/methodology