FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAL INTELLIGENCE CORI XT (CORI XT)
K Number: K252841
·
Decision Dec 5, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
22
Review Days
88
Basic Information
- Device Name
- REAL INTELLIGENCE CORI XT (CORI XT)
- K Number
- K252841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blue Belt Technologies, Inc.
- Date Received
- September 8, 2025
- Decision Date
- December 5, 2025
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Blue Belt Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260601 | REAL INTELLIGENCE CORI | Mar 26, 2026 | Substantially Equivalent |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Jun 25, 2025 | Substantially Equivalent |
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Nov 15, 2024 | Substantially Equivalent |
| K240139 | Real Intelligence CORI | Mar 18, 2024 | Substantially Equivalent |
| K231963 | REAL INTELLIGENCE CORI | Aug 1, 2023 | Substantially Equivalent |
| K221224 | REAL INTELLIGENCE CORI | Aug 19, 2022 | Substantially Equivalent |
| K220958 | Real Intelligence Cori | Jul 27, 2022 | Substantially Equivalent |
| K220255 | REAL INTELLIGENCE CORI | Mar 29, 2022 | Substantially Equivalent |
| K212040 | RI.HIP MODELER | Mar 11, 2022 | Substantially Equivalent |
| K212537 | REAL INTELLIGENCE CORI (CORI) | Nov 3, 2021 | Substantially Equivalent |