Cleared Traditional

K080076 - RX DC X-RAY UNIT

K080076 is an FDA 510(k) clearance for RX DC X-RAY UNIT, manufactured by Cefla S.C.R.L.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K080076 · Cefla S.C.R.L. · Radiology device
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Mar 2008
Decision
63d
Days
Class 2
Risk

K080076 is an FDA 510(k) clearance for the RX DC X-RAY UNIT. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Cefla S.C.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 63 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 - K080076

510(k) Number K080076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date March 14, 2008
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
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 - EHD Unit, X-ray, Extraoral With Timer

All 181
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K080076.
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
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NOMAD PRO X-RAY SYSTEM
K081664 · Aribex, Inc. · Jun 2008
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
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DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
K060640 · Dentamerica · Apr 2006
KODAK MODELS 2100 AND 2200
K060292 · Kodak-Trophy · Mar 2006
K080076 · RX DC X-RAY UNIT
Download PDF Cefla S.C.R.L.