Cleared Traditional

K950112 - CENTRALITE(R)-DLL SERIES

K950112 is an FDA 510(k) clearance for CENTRALITE-DLL SERIES, manufactured by Diacor, Inc.. The device is a Class 1 Radiology device with product code IWE cleared through the Traditional 510(k) pathway after a 217-day FDA review.

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

FDA 510(k) Submission Details - K950112

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.

IWE Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWE Monitor, Patient Position, Light-beam

All 12
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