QQC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Brain Stimulation Programming Planning Software.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5855
- Medical specialty
- Neurology
- FDA definition
- The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
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| Record | Firm | Date |
|---|---|---|
| Bullsai Confirm (K243520) | Turing Medical Technologies, Inc. | 2025-03-28 |
| Brainlab Elements Guide XT, Guide 3.0 (K213930) | Brainlab AG | 2022-04-19 |
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |
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Every clearance here is in the API, with alerts when new ones post.