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FDA 510(k)

Ultimate rTMS for OCD (M-series)

K-Number: K243459 · 2025-04-17

ApplicantBrain Ultimate, Inc.
Decision Date2025-04-17
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ultimate rTMS for OCD (M-series) is the device name listed in this FDA 510(k) record. The listed applicant is Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K243459. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultimate rTMS for OCD (M-series)?

Ultimate rTMS for OCD (M-series) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K243459.

When did Ultimate rTMS for OCD (M-series) receive FDA 510(k) clearance?

Ultimate rTMS for OCD (M-series) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K243459.

Who is the listed applicant for Ultimate rTMS for OCD (M-series)?

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

What is the FDA product code for Ultimate rTMS for OCD (M-series)?

The FDA product code for Ultimate rTMS for OCD (M-series) is QCI.

Other records listing Brain Ultimate, 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.

K261228QuickVision Ultimate rTMSK243460Ultimate rTMSK230735Ultimate rTMS; Yingchi rTMS

Related Devices (Code: QCI)

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.

K260402MeRT SystemWave NeuroscienceK230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLCK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.

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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