FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
Bonelogic
K Number: K223757
·
Decision Dec 8, 2023
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
6
Review Days
358
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Basic Information
- Device Name
- Bonelogic
- K Number
- K223757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Disior, Ltd.
- Date Received
- December 15, 2022
- Decision Date
- December 8, 2023
- 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 |
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Other Clearances by Disior, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253764 | ENOS Software Guided External Fixation System | Feb 26, 2026 | Substantially Equivalent |
| K250023 | SMART PCFD | Sep 29, 2025 | Substantially Equivalent |
| K240736 | SMART Bun-Yo-Matic X-Ray | Jul 2, 2024 | Substantially Equivalent |
| K240642 | SMART Bun-Yo-Matic CT | Jun 20, 2024 | Substantially Equivalent |
| K203290 | Bonelogic | Feb 5, 2021 | Substantially Equivalent |