Module Integrated Radiotherapy System (Mirs)

FDA 510(k) K090182 · Nuclemed S.A.

Substantially Equivalent

510(k) numberK090182

Submission

Device name
Module Integrated Radiotherapy System (Mirs)
Applicant
Nuclemed S.A.
Hudson, NH, US
Received
January 26, 2009
Decision date
May 4, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUJ – System, Planning, Radiation Therapy Treatment
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

Other 510(k)s with product code MUJ

510(k)DeviceApplicantDecision
K260750Virtual Cone (1.0)MUJ · Traditional Varian Medical Systems, Inc.07/08/2026SE
K253050RadOncAIMUJ · Traditional Informai06/18/2026SE
K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional Philips Medical Systems Nederland B.V.05/27/2026SE
K252784eXaSkin PlusMUJ · Traditional Anatomical Geometry S.L.05/22/2026SE
K253078ART.1-USMUJ · Traditional Seetreat Pty, Ltd.05/14/2026SE
K252304syngo.via RT Image Suite VC10MUJ · Traditional Varian Medical Systems, Inc.03/18/2026SE
K260308TrueFit BolusMUJ · Special Adaptiiv Medical Technologies, Inc.02/19/2026SE
K252002Monaco RTP System (6.3)MUJ · Traditional Elekta Solutions AB02/19/2026SE
K253091ART-Plan+ (v3.1.0)MUJ · Traditional Therapanacea Sas12/23/2025SE
K252109RayStation (2024A SP3)MUJ · Traditional RaySearch Laboratories AB (PUBL)12/22/2025SE

More from RaySearch Laboratories AB (PUBL)

510(k)DeviceDecision
K090190Win-Neus Stereotactic Surgery Treatment Planning SystemHAW · Traditional 10/09/2009SE

Questions and answers

When was Module Integrated Radiotherapy System (Mirs) cleared by the FDA?

Module Integrated Radiotherapy System (Mirs) (K090182) received a 510(k) decision of Substantially Equivalent on May 4, 2009, 98 days after the submission was received.

What is the product code of K090182?

The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.