Cleared Traditional

K860472 - NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (FDA 510(k) Clearance)

Class I Radiology device.

K860472 · Nuclear Diagnostics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
147d
Days
Class 1
Risk

K860472 is an FDA 510(k) clearance for the NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Springfield, US). The FDA issued a Cleared decision on July 3, 1986 after a review of 147 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 Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K860472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date July 03, 1986
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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.