Chrysalis Intelligence · Sponsors · Brainsway , Ltd.

Brainsway , Ltd.

Jerusalem, IL · 8 510(k) clearances

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Total clearances
8
2020-08-21 → 2025-11-07
Last 12 months
2
Product codes
2
Most recent
2025-11-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OBP Transcranial Magnetic Stimulator Class II Neurology 6 2025-11-07
QMD Transcranial Magnetic Stimulation System For Smoking Cessation Class II Neurology 2 2021-04-16
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2025-11-07 K251391 BrainsWay Deep TMS System OBP Class II Neurology
2025-09-13 K251449 BrainsWay Deep TMS System OBP Class II Neurology
2024-05-31 K222196 Deep TMS System OBP Class II Neurology
2022-08-26 K220819 BrainsWay Deep TMS System OBP Class II Neurology
2021-08-17 K210201 Deep Transcranial Magnetic Stimulation (DTMS) System OBP Class II Neurology
2021-04-23 K203735 Brainsway Deep TMS System OBP Class II Neurology
2021-04-16 K203616 Brainsway Deep (DTMS) System QMD Class II Neurology
2020-08-21 K200957 Brainsway Deep TMS System QMD Class II Neurology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence