510(k) · Radiology

CEPHX- Cephalometric Analysis Software

by Orca Dental AI LTD

CEPHX- Cephalometric Analysis Software is an AI-enabled medical device from Orca Dental AI LTD that the U.S. FDA cleared through 510(k) K231396 on January 31, 2024. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK231396
Pathway510(k)
Date of final decision
Company (FDA list)Orca Dental AI LTD
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Orca Dental AI , Ltd.
Applicant locationHerzliya, IL
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. CEPHX- Cephalometric Analysis Software went through this pathway (K231396).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #140 of 161 under that code. Orca Dental AI LTD has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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