Cleared Traditional

K946260 - NTBS-1417, 1436, TBS-1417 (FDA 510(k) Clearance)

Class I Radiology device.

K946260 · Scott Imaging Intl., Inc. · Radiology device
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Mar 1995
Decision
108d
Days
Class 1
Risk

K946260 is an FDA 510(k) clearance for the NTBS-1417, 1436, TBS-1417. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Scott Imaging Intl., Inc. devices

Submission Details

510(k) Number K946260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date March 31, 1995
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
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.