# K080601: Ergo++ Version 1.7

- Pathway: 510(k) (Traditional)
- Applicant: 3D Line Medical Systems S.R.L.
- Decided: Jun 6, 2008 after 95 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001163 (2000). 4 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001163: DMLC IV-Ergo, 3D Line USA, Inc. (2000) Summary page 2.
- K031281: Ergo SRS, 3D Line USA, Inc. (2003) Summary page 1.
- K013535: Evtool Model # V. 1.0, 3D Line USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K110730: Monaco RTP System (2011), 8 descendants of its own

## Recalls of this device
- Sep 1, 2017 · Class II · Z-0234-2018: Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
- Dec 11, 2009 · Not classified · Z-2645-2011: ERGO Release 1.6.3 is overestimating the MU values.

## Indications for use
ERGO++ is a treatment planning system. 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/K080601
Methodology: https://510kreport.com/methodology