FDA 510(k) Clearance for Hefei Meyer’s mDX-15P Dental CBCT

The FDA has cleared the mDX-15P Series dental cone-beam computed tomography system from Hefei Meyer Optoelectronic Technology via the 510(k) pathway. The device is classified under product code OAS.

• The mDX-15P Series is a dental cone-beam CT system manufactured by Hefei Meyer Optoelectronic Technology.
• FDA clearance was granted via the 510(k) premarket notification pathway; product code OAS.
• The application was reviewed by the FDA’s Radiology branch.

Automated summary

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