Cleared Traditional

K063837 - SIGMA M

K063837 is an FDA 510(k) clearance for SIGMA M, manufactured by Instrumentarium Dental, Palodex Group OY. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K063837 · Instrumentarium Dental, Palodex Group OY · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
188d
Days
Class 2
Risk

K063837 is an FDA 510(k) clearance for the SIGMA M. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Instrumentarium Dental, Palodex Group OY (Tuusula, FI). The FDA issued a Cleared decision on July 2, 2007 after a review of 188 days - an extended review 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: 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 Instrumentarium Dental, Palodex Group OY devices

FDA 510(k) Submission Details - K063837

510(k) Number K063837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date July 02, 2007
Days to Decision 188 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
81d slower than avg
Panel avg: 107d · This submission: 188d
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
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K063837.
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