Cleared Traditional

K950112 - CENTRALITE(R)-DLL SERIES (FDA 510(k) Clearance)

Class I Radiology device.

K950112 · Diacor, Inc. · Radiology device
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Aug 1995
Decision
217d
Days
Class 1
Risk

K950112 is an FDA 510(k) clearance for the CENTRALITE(R)-DLL SERIES. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 16, 1995 after a review of 217 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 Diacor, Inc. devices

Submission Details

510(k) Number K950112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1995
Decision Date August 16, 1995
Days to Decision 217 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
110d slower than avg
Panel avg: 107d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.