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Brainlab AG

DE

Last updated September 17, 2026

Information

Country
DE
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (247)

Page 5 of 5
DeviceModel / ReferenceRegistriesClassStatus
Patxfer Rt K040931
FDA 510(k)
Class IIActive
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT K243698
FDA 510(k)
Class IIActive
Brainscan Radiosurgery Module K920879
FDA 510(k)
Class IIActive
Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential, Cranial Unlimited K092467
FDA 510(k)
Class IIActive
Advanced Viewer K132763
FDA 510(k)
Class IIActive
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) K223106
FDA 510(k)
Class IIActive
Vectorvision Spine Module K981508
FDA 510(k)
Class IIActive
Rt Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis K142108
FDA 510(k)
Class IIActive
Iplan! K041703
FDA 510(k)
Class IIActive
RT 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 RT K250440
EUDAMEDFDA 510(k)FDA UDI
Class IIActive
Table Tilt Device K033316
FDA 510(k)
Class IIActive
Kolibri Igs Systems K014256
FDA 510(k)
Class IIActive
Exactrac Vero K122451
FDA 510(k)
Class IIActive
Digital Lightbox K080608
FDA 510(k)
Class IIActive
Intuition Image K032511
FDA 510(k)
Class IIActive
Vectorvision Spine K053159
FDA 510(k)
Class IIActive
Vectorvision Hip And Hip Sr K072573
FDA 510(k)
Class IIActive
Microscope Navigation K190250
FDA 510(k)
Class IIActive
Frameless Radiosurgery Components K053500
FDA 510(k)
Class IIActive
Navivision K062086
FDA 510(k)
Class IIActive
Digital Lightbox K093117
FDA 510(k)
Class IIActive
Iplan Rt K103246
FDA 510(k)
Class IIActive
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM K170816
FDA 510(k)
Class IIActive
Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243432
FDA 510(k)
Class IIActive
Exactrac X-Ray X-Ray K120789
FDA 510(k)
Class IIActive
Vectorvision K962939
FDA 510(k)
Class IIActive
Exactrac 5.5 K072506
FDA 510(k)
Class IIActive
Spine & Trauma Navigation Instruments K252562
FDA 510(k)
Class IIActive
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System K210989
FDA 510(k)
Class IIActive
Iplan Flow K053164
FDA 510(k)
Class IIActive
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI K223288
FDA 510(k)
Class IIActive
Modification To Vectorvision Trauma K062358
FDA 510(k)
Class IIActive
Dash Knee K102251
FDA 510(k)
Class IIActive
Iplan! Digital Templating K042543
FDA 510(k)
Class IIActive
Cranial 4Pi Immobilization K202050
FDA 510(k)
Class IIActive
Ci Knee, Ci Mi Tkr K052966
FDA 510(k)
Class IIActive
Uni-Knee 2.0 K080678
FDA 510(k)
Class IIActive
Quentry Dose Review K141199
FDA 510(k)
Class IIActive
Iplan! Flow K041330
FDA 510(k)
Class IIActive
Disposable Pre-calibrated Suction K201752
FDA 510(k)
Class IIActive
Vectorvision Osteotomy K042513
FDA 510(k)
Class IIActive
Dash Hip K110021
FDA 510(k)
Class IIActive
Exac Trac 2.0 (novalis Body Module) K003285
FDA 510(k)
Class IIActive
Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee Unlimited K073615
FDA 510(k)
Class IIActive
Exactrac 4.0 And Exactrac X-Ray 6d K040585
FDA 510(k)
Class IIActive
Vectorvision2 K983831
FDA 510(k)
Class IIActive
Modeification To Iplan Rt Dose K080888
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Brainlab Ltd. PETACH-TIKVA Central · IL FEI 3005225421