Brain Stimulation Programming Planning Software.
The Brain Stimulation Programming Planning Software is a prescription neurology device intended to assist clinicians in planning stimulation programming for implanted brain stimulators, supporting the optimization of deep brain stimulation or similar implanted neuromodulation therapies. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 882.5855 in the Neurology specialty. It carries product code QQC and is not an implant and not life-sustaining.
Basic Information
- Product Code
- QQC
- Device Class
- FDA class 2
- Regulation Number
- 882.5855
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243520 | Bullsai Confirm | Mar 28, 2025 | Substantially Equivalent | Turing Medical Technologies, Inc. |
| K213930 | Brainlab Elements Guide XT, Guide 3.0 | Apr 19, 2022 | Substantially Equivalent | Brainlab AG |
| DEN210003 | SureTune4 Software | Aug 23, 2021 | Unknown | Medtronic Neuromodulation |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.