Identity
- Trade Name
- Clear Guide CORE FDA UDI
- Generic Name
- Ultrasound imaging 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-CORE13 model is a tablet PC with a 13" screen. FDA UDI
- Model / Reference
- CGCORE13 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-CORE13 model is a tablet PC with a 13" screen. FDA UDI
Identifiers
- Catalog Number
- CG-CORE-13 FDA UDI
- Primary DI / UDI-DI
- B201CGCORE130 FDA UDI
- 510(k) Number
- K201898 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Ultrasound imaging 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
Category: Portable computerOptical surgical navigation device tracking system workstation, mobileUltrasound imaging system workstationStereotactic surgery system workstation
Clear Guide CORE by Clear Guide Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic surgery system workstation.
- StealthStation® AXIEM™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Geniant Cranial — Koh Young Technology, Inc. · Class II
- StealthStation® AXIEM™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Synergy — MEDTRONIC NAVIGATION, INC. · Class II
- Stealthstation® S7™ — MEDTRONIC NAVIGATION, INC. · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
Cleared under the same submission
K201898 also covers:
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 6ae869dc-5a4a-43ae-9eb4-78b22c031706 37 fields · synced Jun 9, 2026