510(k) K231396
K231396 is an FDA 510(k) premarket notification submitted by Orca Dental AI , Ltd. for the device "CEPHX- Cephalometric Analysis Software". The FDA issued a decision of Substantially Equivalent on Jan 31, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Orca Dental AI , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 2024
- Date Received
- May 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type