Cleared Traditional

K062403 - IMAX CEPH DIGITAL X-RAY SENSOR

K062403 is an FDA 510(k) clearance for IMAX CEPH DIGITAL X-RAY SENSOR, manufactured by Owandy. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K062403 · Owandy · Radiology device
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Nov 2006
Decision
89d
Days
Class 2
Risk

K062403 is an FDA 510(k) clearance for the IMAX CEPH DIGITAL X-RAY SENSOR. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Owandy (Ormond Beach, US). The FDA issued a Cleared decision on November 14, 2006 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062403

510(k) Number K062403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date November 14, 2006
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

All 206
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K062403.
DIGORA PCT/DIGIPOD
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I-CAT SCANNER
K061284 · Imaging Sciences Intl., Inc. · Jul 2006
UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)
K053172 · Owandy Sas · Jun 2006