# Brainsway, Ltd.

- Location (FDA's records): Jerusalem, IL
- FDA decisions: 11 (2013–2025): 11 510(k) clearances
- Product codes: OBP (8), QMD (2), QCI (1)
- 510(k) review time since 2016: median 169 days, against 132 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 13 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neuronetics, Inc.: 3 (https://510kreport.com/company/neuronetics)
- Brainways, Ltd.: 2 (https://510kreport.com/company/brainways)
- Magnus Medical, Inc.: 1 (https://510kreport.com/company/magnus-medical)
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)

## Firms that cite its devices most
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)
- Neuronetics, Inc.: 1 (https://510kreport.com/company/neuronetics)
- Neuromodulatory Devices & Applications: 1 (https://510kreport.com/company/neuromodulatory-devices-applications)

## Its most-cited devices
- K210201: Deep Transcranial Magnetic Stimulation (DTMS) System (2021), cited by 3
- K122288: Brainsway Deep TMS System (2013), cited by 3
- K222196: Deep TMS System (2024), cited by 2
- K173540: Brainsway Deep (DTMS) System (2018), cited by 2
- K183303: Brainsway Deep TMS System (2019), cited by 1
- K200957: Brainsway Deep TMS System (2020), cited by 1

## Recent decisions
- K251391: BrainsWay Deep TMS System (Nov 7, 2025)
- K251449: BrainsWay Deep TMS System (Sep 13, 2025)
- K222196: Deep TMS System (May 31, 2024)
- K220819: BrainsWay Deep TMS System (Aug 26, 2022)
- K210201: Deep Transcranial Magnetic Stimulation (DTMS) System (Aug 17, 2021)
- K203735: Brainsway Deep TMS System (Apr 23, 2021)
- K203616: Brainsway Deep (DTMS) System (Apr 16, 2021)
- K200957: Brainsway Deep TMS System (Aug 21, 2020)

Source page: https://510kreport.com/company/brainsway