Device
CephX is a standalone software device intended for use by dental and orthodontic professionals for the viewing, analysis, and measurement of 2D cephalometric x-ray images. The soft...
Manufacturer
ORCA DENTAL AI LTD
ORCA DENTAL AI LTD
Model: 4.2
DI: 07290019703006
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
CephX is a standalone software device intended for use by dental and orthodontic professionals for the viewing, analysis, and measurement of 2D cephalometric x-ray images. The software provides automated tracing, anatomical landmark detection, and treatment planning tools to assist clinicians in orthodontic evaluation.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8832ac08-61a9-4ea2-bad2-85a053e2e1d9
Distribution Status:
In Commercial Distribution
DUNS Number:
514417294
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290019703006
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57812
Name: Radiology DICOM image processing application software
Definition:
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K231396
Supplement Number:
000