Cleared Traditional

K040382 - CRANEX BASEX D OR CRANEX EXCEL D

K040382 is an FDA 510(k) clearance for CRANEX BASEX D OR CRANEX EXCEL D, manufactured by Soredex Palodex Group OY. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K040382 · Soredex Palodex Group OY · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
147d
Days
Class 2
Risk

K040382 is an FDA 510(k) clearance for the CRANEX BASEX D OR CRANEX EXCEL D. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Soredex Palodex Group OY (Helsinki, FI). The FDA issued a Cleared decision on July 13, 2004 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Soredex Palodex Group OY devices

FDA 510(k) Submission Details - K040382

510(k) Number K040382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date July 13, 2004
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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 96
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K040382.
PORTABLE X-RAY SYSTEM, MODEL PORT-X II
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TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
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TROPHYPAN AND TROPHYPAN C
K033690 · Trophy Radiologie · Feb 2004
ORTHOPHOS XG DS/CEPH
K033073 · Sirona Dental Systems GmbH · Oct 2003