Monaco RTP System

510(k) K183037

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK183037	Date4 Dec 2018Cleared	StatusActive

6 recalls · 5 ongoing · FDA

- Ongoing Z-2563-2021 FDA Class II initiated 14 Sep 2021
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
- Ongoing Z-2406-2021 FDA Class II initiated 26 Jul 2021
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
- Ongoing Z-1825-2020 FDA Class II initiated 16 Apr 2020
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
- Ongoing Z-0670-2020 FDA Class II initiated 22 Nov 2019
Monaco is using the incorrect energy when optimizing and calculating dose.
- Ongoing Z-2560-2019 FDA Class II initiated 4 Sep 2019
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
- Terminated Z-0965-2019 FDA Class II initiated 8 Feb 2019
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

1 jurisdiction

United States — FDA 510(k) Active

510(k)