Cleared Traditional

K973162 - DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (FDA 510(k) Clearance)

Class I General Hospital device.

K973162 · Hogan & Hartson · General Hospital
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Nov 1997
Decision
90d
Days
Class 1
Risk

K973162 is an FDA 510(k) clearance for the DUAL RADIATION TARGETING SYSTEM DRTS DRAPE. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 892.5780 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K973162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1997
Decision Date November 20, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
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.