# K151233: Monaco

- Pathway: 510(k) (Traditional)
- Applicant: Impac Medical Systems, Inc.
- Decided: Jul 7, 2015 after 60 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 184 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132971: Monaco, Impac Medical Systems, Inc. (2013) Summary page 5.
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation, Ge Hungary Kft (2014) Summary page 5.

## Most influential descendants
- 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
- K213787: Monaco RTP System (2022), 2 descendants of its own
- K223233: Monaco RTP System (2023), 1 descendant of its own

## Recalls of this device
- Feb 28, 2023 · Class II · Z-1233-2023: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
- Jul 3, 2019 · Class II · Z-2091-2019: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectl
- Jan 10, 2017 · Class II · Z-1044-2017: Incorrect dose after editing beam number an wedge angle.
- Dec 21, 2016 · Class II · Z-1009-2017: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
- Nov 3, 2016 · Class II · Z-0660-2017: Incorrect Dose when using the reset function.
- Sep 29, 2016 · Class II · Z-0076-2017: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is sc
- May 18, 2016 · Class II · Z-1879-2016: When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
- Oct 16, 2015 · Class II · Z-0181-2016: Unintended update of Dose and MU and Incorrect Assignment of Bolus.
- Sep 15, 2015 · Class II · Z-0112-2016: Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

## Indications for use
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: * contouring * image manipulation * simulation + image fusion * plan optimization * QA and plan review

Source page: https://510kreport.com/device/K151233
Methodology: https://510kreport.com/methodology