Cleared Traditional

K024186 - X-VIEW

K024186 is an FDA 510(k) clearance for X-VIEW, manufactured by Sometech Corporation. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K024186 · Sometech Corporation · Radiology device
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Apr 2004
Decision
469d
Days
Class 2
Risk

K024186 is an FDA 510(k) clearance for the X-VIEW. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Sometech Corporation (Norcross, US). The FDA issued a Cleared decision on April 1, 2004 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Sometech Corporation devices

FDA 510(k) Submission Details - K024186

510(k) Number K024186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2002
Decision Date April 01, 2004
Days to Decision 469 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
362d slower than avg
Panel avg: 107d · This submission: 469d
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 97
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