Identity
- Trade Name
- Clear Guide CORE FDA UDI
- Generic Name
- Stereotactic surgery system workstation FDA UDI
- Device Name
- The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. FDA UDI
- Model / Reference
- CGCORE24MR FDA UDI
- Description
- The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. FDA UDI
Identifiers
- Catalog Number
- CG-CORE24-MR FDA UDI
- Primary DI / UDI-DI
- B201CGCORE24MR0 FDA UDI
- 510(k) Number
- K171677 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Stereotactic surgery system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Optical surgical navigation device tracking system workstation, mobileUltrasound imaging system workstationStereotactic surgery system workstationPanel computer
Clear Guide CORE by Clear Guide Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Panel computer.
- Atmo Biosciences — Atmo Biosciences, Ltd. · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Clear Guide Medical
Sources (1)
- FDA UDI 122bf2f4-3750-4694-947c-a08e77713994 37 fields · synced Jun 9, 2026