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FDA 510(k)

MagVenture TMS Atlas Neuro Navigation System

K-Number: K221544 · 2023-03-17

ApplicantTonica Elektronik A/S
Decision Date2023-03-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MagVenture TMS Atlas Neuro Navigation System is a medical device manufactured by Tonica Elektronik A/S. It received FDA 510(k) clearance on 2023-03-17 under approval number K221544. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagVenture TMS Atlas Neuro Navigation System?

MagVenture TMS Atlas Neuro Navigation System is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Tonica Elektronik A/S. The 510(k) number is K221544.

When was MagVenture TMS Atlas Neuro Navigation System approved by the FDA?

MagVenture TMS Atlas Neuro Navigation System received FDA 510(k) clearance on 2023-03-17, under approval number K221544.

What company makes MagVenture TMS Atlas Neuro Navigation System?

MagVenture TMS Atlas Neuro Navigation System is manufactured by Tonica Elektronik A/S.

What is the FDA product code for MagVenture TMS Atlas Neuro Navigation System?

The FDA product code for MagVenture TMS Atlas Neuro Navigation System is HAW.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Tonica Elektronik A/S

K160280MagPro R20 K172667MagVita TMS Therapy w/MagPro R20 K171967MagVita TMS Therapy System K171481MagVita TMS Therapy System K170114MagVita TMS Therapy - w/MagPro R20 K162873MEP Monitor

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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