FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Dental Cone Beam Computed Tomography System
K Number: K243337
·
Decision Apr 17, 2025
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
2
Review Days
174
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Basic Information
- Device Name
- Dental Cone Beam Computed Tomography System
- K Number
- K243337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Yofo Medical Technology Co., Ltd.
- Date Received
- October 25, 2024
- Decision Date
- April 17, 2025
- Product Code
- OAS
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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Other Clearances by Yofo Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260662 | Dental Cone Beam Computed Tomography System | Jun 4, 2026 | Substantially Equivalent |