Cleared Traditional

VIDEO IMAGE PROCESSOR (K828621) - FDA 510(k) Clearance

K828621 · Pie Data, Inc. · Radiology device
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Jan 1983
Decision
98d
Days
-
Risk

K828621 is an FDA 510(k) clearance for the VIDEO IMAGE PROCESSOR.

Submitted by Pie Data, Inc. (Singer Island, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 98 days - within the typical 510(k) review window.

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

View all Pie Data, Inc. devices

Submission Details

510(k) Number K828621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1982
Decision Date January 14, 1983
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -