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510(k) K190664

Device
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Applicant
Brainlab AG
510(k) number
K190664
Product code
MUJ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-12
Date received
2019-03-15
Regulation
892.5050
Classification name
System, Planning, Radiation Therapy Treatment
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rainer Birkenbach
Address
Olof-Palme-Str 9 Munich DE 81829 81829

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MUJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.2026-05-27
K252784eXaSkin PlusAnatomical Geometry S.L.2026-05-22
K253078ART.1-USSeetreat Pty, Ltd.2026-05-14
K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.2026-03-18
K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.2026-02-19
K252002Monaco RTP System (6.3)Elekta Solutions AB2026-02-19
K253091ART-Plan+ (v3.1.0)Therapanacea Sas2025-12-23
K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)2025-12-22
K252863ClearCalc Model RADCA V2.6Radformation, Inc.2025-12-19
K250963PlanOne 1Cosylab Jsc, Control System Laboratory2025-11-20
K250064Dose+ (1.0)Mvision AI OY2025-09-04
K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTBrainlab AG2025-06-17
K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL)2025-04-17
K242748OncospaceOncospace, Inc.2025-04-11
K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3RaySearch Laboratories AB (PUBL)2025-04-04