FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ClearPoint Maestro Brain Model
K Number: K213645
·
Decision Aug 8, 2022
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
12
Review Days
263
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ClearPoint Maestro Brain Model
- K Number
- K213645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ClearPoint Neuro, Inc.
- Date Received
- November 18, 2021
- Decision Date
- August 8, 2022
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
Synapse PACS (7.6.0)
FDA 510(k)
FDA Class 2
·Radiology
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Brainomix 360 Hyperdensity
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by ClearPoint Neuro, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243657 | ClearPoint System (Software Version 3.0) | Jan 24, 2025 | Substantially Equivalent |
| DEN240023 | SmartFlow Neuro Cannula | Nov 13, 2024 | Unknown |
| K233703 | Bone Anchor (NGS-BA-01) | Apr 26, 2024 | Substantially Equivalent |
| K233141 | SmartFrame OR | Jan 12, 2024 | Substantially Equivalent |
| K233155 | ClearPointer Optical Navigation Wand | Jan 12, 2024 | Substantially Equivalent |
| K233144 | ClearPoint Bone Screw Fiducials | Jan 12, 2024 | Substantially Equivalent |
| K233243 | ClearPoint System (Software Version 2.2) | Nov 27, 2023 | Substantially Equivalent |
| K232102 | ClearPoint Array System (Version 1.2) | Sep 15, 2023 | Substantially Equivalent |
| K222519 | ClearPoint System | Sep 16, 2022 | Substantially Equivalent |
| K214040 | ClearPoint Array System (version 1.1) | Apr 12, 2022 | Substantially Equivalent |