QuickVision Ultimate rTMS— 510(k) K261228

Name: FDA 510(k) clearance K261228
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Brain Ultimate, Inc.

FDA 510(k) clearance K261228 for QuickVision Ultimate rTMS, Substantially Equivalent on 2026-08-14. Applicant: Brain Ultimate, Inc.. Device class: 2.

Clearance details

Applicant: Brain Ultimate, Inc.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2026-04-15
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)2026-03-20
K253098 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)2026-03-20

More clearances from Brain Ultimate, Inc.

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K243459 — Ultimate rTMS for OCD (M-series)2025-04-17
K243460 — Ultimate rTMS2025-04-17
K230735 — Ultimate rTMS; Yingchi rTMS2023-09-13

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.