Cleared Traditional

K946261 - MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (FDA 510(k) Clearance)

Class I Radiology device.

K946261 · Scott Imaging Intl., Inc. · Radiology device
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Feb 1995
Decision
64d
Days
Class 1
Risk

K946261 is an FDA 510(k) clearance for the MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on February 15, 1995 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Scott Imaging Intl., Inc. devices

Submission Details

510(k) Number K946261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date February 15, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.