Cleared Traditional

K874750 - VIDEO ANALYZER 4000 (FDA 510(k) Clearance)

Class I Pathology device.

K874750 · Scientific Imaging, Inc. · Pathology device
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Apr 1988
Decision
159d
Days
Class 1
Risk

K874750 is an FDA 510(k) clearance for the VIDEO ANALYZER 4000. Classified as Light, Microscope (product code IBJ), Class I - General Controls.

Submitted by Scientific Imaging, Inc. (Fairfield, US). The FDA issued a Cleared decision on April 25, 1988 after a review of 159 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3600 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientific Imaging, Inc. devices

Submission Details

510(k) Number K874750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date April 25, 1988
Days to Decision 159 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 77d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IBJ Light, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3600
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.