Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ELEKTA OY

K-Number: K041264 · 2004-08-10

ApplicantElekta Neuromag OY
Decision Date2004-08-10
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEKTA OY is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Neuromag OY. It received FDA 510(k) clearance on 2004-08-10 under 510(k) number K041264. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEKTA OY?

ELEKTA OY is a medical device that received FDA 510(k) clearance on 2004-08-10. The listed applicant is Elekta Neuromag OY. The 510(k) number is K041264.

When did ELEKTA OY receive FDA 510(k) clearance?

ELEKTA OY received FDA 510(k) clearance on 2004-08-10, under 510(k) number K041264.

Who is the listed applicant for ELEKTA OY?

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

What is the FDA product code for ELEKTA OY?

The FDA product code for ELEKTA OY is OLX.

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 Elekta Neuromag OY 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.

K091393ELEKTA NEUROMAG WITH MAXFILTERK081430ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDINGK050035ELEKTA NEUROMAG WITH MAXWELL FILTER

Related Devices (Code: OLX)

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.

K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND NeuroK252565PreOp v3Clouds of CareK250239NeuroMatchLVIS CorporationK241513SourcererBrain Electrophysiology Laboratory Company, LLCK233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OYK210199RICOH MEGRicoh Company, Ltd.

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.

↑