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FDA 510(k)

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

K-Number: K190664 · 2019-04-12

ApplicantBrainlab AG
Decision Date2019-04-12
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2019-04-12 under approval number K190664. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review?

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Brainlab AG. The 510(k) number is K190664.

When was RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review approved by the FDA?

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review received FDA 510(k) clearance on 2019-04-12, under approval number K190664.

What company makes RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review?

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review is manufactured by Brainlab AG.

What is the FDA product code for RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review?

The FDA product code for RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review is MUJ.

Related Clinical Trials

NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT02107989 Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database RECRUITING NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42180407 Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities. Frontiers in drug safety and regulation (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41947919 Analysis of Trends in FDA-Recalled Hip Arthroplasty Devices: A Retrospective Review. JB & JS open access (2026)

Other Devices by Brainlab AG

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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