# K031281: Ergo SRS

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line USA, Inc.
- Decided: Dec 23, 2003 after 245 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: 1 generation back to K010784 (2001). 1 ancestor in all.
30 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010784: Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1, Nucletron Corp. (2001) Summary page 1.

## Most influential descendants
- K080601: Ergo++ Version 1.7 (2008), 29 descendants of its own
- K141572: Mosaiq Oncology Information System (2014), 13 descendants of its own
- K183034: MOSAIQ Oncology Information System (2018), 12 descendants of its own
- K091179: Monaco RTP System, Vmat Option (2009), 12 descendants of its own
- K203172: MOSAIQ Oncology Information System (2020), 8 descendants of its own

## Indications for use
ERGO SRS is stereotactic radiosurgery module for DMLCIV-ERGO (KOO1 163). It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3 dimensional radiation therapy.

Source page: https://510kreport.com/device/K031281
Methodology: https://510kreport.com/methodology