Cleared Traditional

K954414 - CENTRALITE BACKPOINTER

K954414 is an FDA 510(k) clearance for CENTRALITE BACKPOINTER, 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 32-day FDA review.

K954414 · Diacor, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
32d
Days
Class 1
Risk

K954414 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 October 23, 1995 after a review of 32 days - a notably fast clearance 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: 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 Diacor, Inc. devices

FDA 510(k) Submission Details - K954414

510(k) Number K954414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1995
Decision Date October 23, 1995
Days to Decision 32 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
75d faster than avg
Panel avg: 107d · This submission: 32d
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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