Cleared Traditional

K893398 - CENTRALITE BACKPOINTER

K893398 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 108-day FDA review.

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

FDA 510(k) Submission Details - K893398

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.

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
Devices cleared under the same product code (IWE) and FDA review panel - the closest regulatory comparables to K893398.
TEC 2101 (MODEL MT-HPLGD)
K941169 · Medtec, Inc. · Jul 1994
TEC 2100 (MODEL MT-LPLGD)
K935760 · Medtec, Inc. · Jan 1994
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
K934519 · Medtec, Inc. · Dec 1993
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K860472 · Nuclear Diagnostics, Inc. · Jul 1986
WALL MOUNTED LASER POSITIONING DEVICE
K801541 · Advantage Medical Systems, Inc. · Aug 1980