Dental Cone-beam Computed Tomography (mDX-15P Series)— 510(k) K261748
Substantially EquivalentHefei Meyer Optoelectronic Technology, Inc.
FDA 510(k) clearance K261748 for Dental Cone-beam Computed Tomography (mDX-15P Series), Substantially Equivalent on 2026-07-23. Applicant: Hefei Meyer Optoelectronic Technology, Inc.. Device class: 2.
Summary
Hefei Meyer Optoelectronic Technology's Dental Cone-beam Computed Tomography (mDX-15P Series) is filed under OAS, dental computed tomography X-ray systems. The record doesn't name the models in the series.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Hefei Meyer filed from Hefei, China. Review took 56 calendar days (May 28 to July 23, 2026).
Clearance details
- Applicant
- Hefei Meyer Optoelectronic Technology, Inc.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hefei, CN
Recent devices under product code OAS
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