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FDA 510(k)

EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)

K-Number: K983660 · 1999-07-14

ApplicantBrainlab, Inc.
Decision Date1999-07-14
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab, Inc.. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K983660. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)?

EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Brainlab, Inc.. The 510(k) number is K983660.

When did EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) receive FDA 510(k) clearance?

EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) received FDA 510(k) clearance on 1999-07-14, under 510(k) number K983660.

Who is the listed applicant for EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)?

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

What is the FDA product code for EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)?

The FDA product code for EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) is LHN.

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, Inc. 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.

K962939VECTORVISION

Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.

Official Source

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

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