Cleared Traditional

HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY (K842691) - FDA 510(k) Clearance

K842691 · Health Technology Services · Neurology device
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Nov 1984
Decision
117d
Days
-
Risk

K842691 is an FDA 510(k) clearance for the HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY.

Submitted by Health Technology Services (Elmhurst, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K842691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1984
Decision Date November 05, 1984
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -