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FDA 510(k)

QuickVision Ultimate rTMS

K-Number: K261228 · 2026-08-14

ApplicantBrain Ultimate, Inc.
Decision Date2026-08-14
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QuickVision Ultimate rTMS 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 2026-08-14 under 510(k) number K261228. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuickVision Ultimate rTMS?

QuickVision Ultimate rTMS is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K261228.

When did QuickVision Ultimate rTMS receive FDA 510(k) clearance?

QuickVision Ultimate rTMS received FDA 510(k) clearance on 2026-08-14, under 510(k) number K261228.

Who is the listed applicant for QuickVision Ultimate rTMS?

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 QuickVision Ultimate rTMS?

The FDA product code for QuickVision Ultimate rTMS is OBP.

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.

K243460Ultimate rTMSK243459Ultimate rTMS for OCD (M-series)K230735Ultimate rTMS; Yingchi rTMS

Related Devices (Code: OBP)

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.

K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.K251391BrainsWay Deep TMS SystemBrainsway , Ltd.

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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