Cleared Traditional

K163519 - RX DC

K163519 is an FDA 510(k) clearance for RX DC, manufactured by Cefla S.C.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K163519 · Cefla S.C. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
29d
Days
Class 2
Risk

K163519 is an FDA 510(k) clearance for the RX DC. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Cefla S.C. (Imola, IT). The FDA issued a Cleared decision on January 13, 2017 after a review of 29 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.

View all Cefla S.C. devices

FDA 510(k) Submission Details - K163519

510(k) Number K163519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2016
Decision Date January 13, 2017
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
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 Consultant

Isemed S.R.L.
MAURIZIO PANTALEONI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 86
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