Cleared Traditional

K860472 - NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS

K860472 is an FDA 510(k) clearance for NUCLEAR LASER ALIGNMENT SYSTEM FOR CARD..., manufactured by Nuclear Diagnostics, Inc.. The device is a Class 1 Radiology device with product code IWE cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K860472 · Nuclear Diagnostics, Inc. · Radiology device
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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

FDA 510(k) Submission Details - K860472

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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.