# QCI: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

- Device class: 2; regulation: 21 CFR 882.5802; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 225 days (middle half 63–317)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 1
- 2020: 1
- 2022: 1
- 2023: 3
- 2024: 1
- 2025: 1

## Most-cited predicates
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (2020), cited by 4
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (2022), cited by 4
- DEN170078: Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (2018), cited by 3
- K183303: Brainsway Deep TMS System (2019), cited by 1
- K230657: BTL-99-OC (2024), cited by 1
- K221129: CloudTMS for OCD (2023), cited by 1

Source page: https://510kreport.com/product-code/QCI
Data by year (CSV): https://510kreport.com/product-code/QCI.csv