MEGA-TMS
FDA 510(k) clearance K192823 · decided 2021-08-13
Clearance details
- K-number
- K192823
- Device name
- MEGA-TMS
- Applicant
- Soterix Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-02
- Decision date
- 2021-08-13
- Days to decision
- 681 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| BraiN20® (BraiN20) (K253301) | Time IS Brain, S.L. | 2026-06-27 |
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| Natus Ultrapro S100 (982A0594) (K243495) | Natus Neurology Incorporated | 2024-12-12 |
| Delphi Stimulator (K242345) | Quantalx Neuroscience | 2024-11-05 |
| SafeOp 3: Neural Informatix Systeem (K234092) | Alphatec Spine, Inc. | 2024-04-19 |
| MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080) | Soterix Medical, Inc. | 2024-03-25 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292) | Inomed Medizintechnik GmbH | 2023-10-27 |
| Cadwell Guardian (K230415) | Cadwell Industries, Inc. | 2023-08-17 |
| SafeOp 2: Neural Informatix System (K213849) | Alphatec Spine, Inc. | 2022-03-09 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166) | Inomed Medizintechnik GmbH | 2022-01-07 |
| Neuro-IOM system with Neuro-IOM.NET software (K190703) | Neurosoft , Ltd. | 2021-05-22 |
Recalls involving this device
No recalls on record reference this clearance.