# K102915: Viewray Treatment Planning and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: Jan 12, 2011 after 103 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010975 (2001). 37 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092871: Trilogy MX, Varian Medical Systems, Inc. (2009) Summary page 1.
- K091492: Modification to Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K162393: The ViewRay (MRIdian) Linac System (2017), 8 descendants of its own
- K170751: MRIdian Linac System with 138-leaf Collimator (2017), 7 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own
- K190178: Monaco RTP System (2019), 4 descendants of its own
- K202789: Monaco Rtp System (2021), 3 descendants of its own

## Recalls of this device
- May 4, 2021 · Class II · Z-1836-2021: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

## Indications for use
Use of the ViewRaynM Treatment Planning and Delivery System is indicated for stereoitactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K102915
Methodology: https://510kreport.com/methodology