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FDA 510(k)

BRAINSCAN BRACHYTHERAPY MODULE

K-Number: K920880 · 1992-12-30

ApplicantBrainlab
Decision Date1992-12-30
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINSCAN BRACHYTHERAPY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab. It received FDA 510(k) clearance on 1992-12-30 under 510(k) number K920880. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINSCAN BRACHYTHERAPY MODULE?

BRAINSCAN BRACHYTHERAPY MODULE is a medical device that received FDA 510(k) clearance on 1992-12-30. The listed applicant is Brainlab. The 510(k) number is K920880.

When did BRAINSCAN BRACHYTHERAPY MODULE receive FDA 510(k) clearance?

BRAINSCAN BRACHYTHERAPY MODULE received FDA 510(k) clearance on 1992-12-30, under 510(k) number K920880.

Who is the listed applicant for BRAINSCAN BRACHYTHERAPY MODULE?

The FDA 510(k) record lists Brainlab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAINSCAN BRACHYTHERAPY MODULE?

The FDA product code for BRAINSCAN BRACHYTHERAPY MODULE is KXK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brainlab as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992916BRAINLAB STEREOTACTIC ARCK920879BRAINSCAN RADIOSURGERY MODULE

Related Devices (Code: KXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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