CEPHX- Cephalometric Analysis Software

FDA 510(k) K231396 · Orca Dental AI , Ltd.

Substantially Equivalent

510(k) numberK231396

Submission

Device name
CEPHX- Cephalometric Analysis Software
Applicant
Orca Dental AI , Ltd.
Herzliya, IL
Received
May 15, 2023
Decision date
January 31, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was CEPHX- Cephalometric Analysis Software cleared by the FDA?

CEPHX- Cephalometric Analysis Software (K231396) received a 510(k) decision of Substantially Equivalent on January 31, 2024, 261 days after the submission was received.

What is the product code of K231396?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.