Cleared Traditional

K893398 - CENTRALITE BACKPOINTER (FDA 510(k) Clearance)

Class I Radiology device.

K893398 · Diacor, Inc. · Radiology device
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Aug 1989
Decision
108d
Days
Class 1
Risk

K893398 is an FDA 510(k) clearance for the CENTRALITE BACKPOINTER. 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 17, 1989 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 892.5780 - 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 K893398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date August 17, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
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 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.