# K090182: Module Integrated Radiotherapy System (Mirs)

- Pathway: 510(k) (Traditional)
- Applicant: Nuclemed S.A.
- Decided: May 4, 2009 after 98 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: 4 generations back to K914698 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010464: Radcalc, Model V.4.0, Lifeline Software, Inc. (2001)
- K082606: Commissioning Data Management System (CDMS), D3 Radiation Planning (2008) Summary page 1.
- K010784: Plato SRS Stereotactic Radiosurgery Planning System,Model 2.0, Plato Ifs Image Fusion Software, Model 2.1, Nucletron Corp. (2001)
- K973936: Focus RTP System, Computerized Medical Systems, Inc. (1998) Summary page 1.
- K002147: FOCUS, Computerized Medical Systems, Inc. (2000) Summary page 1.
- K031975: Imsure, Prodigm, Inc. (2003) Summary page 1.
- K080601: Ergo++ Version 1.7, 3D Line Medical Systems S.R.L. (2008) Summary page 1.
- K951581: PINNACLE3 Apex, Adac Laboratories (1996) Summary page 1.
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System, Adac Laboratories (2000) Summary page 1.
- K915691: Focus RTP, Computerized Medical Systems, Inc. (1995) Summary page 1.

## Indications for use
MIRS TM is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, as conventional therapy, Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.

Source page: https://510kreport.com/device/K090182
Methodology: https://510kreport.com/methodology