Cleared Traditional

CEPHX- Cephalometric Analysis Software

K231396 · Orca Dental AI , Ltd. · Radiology

Jan 2024

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K231396 is an FDA 510(k) clearance for the CEPHX- Cephalometric Analysis Software, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Orca Dental AI , Ltd. (Herzliya, IL). The FDA issued a Cleared decision on January 31, 2024, 261 days after receiving the submission on May 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K231396 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2023
Decision Date	January 31, 2024
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF