Cleared Traditional

K874750 - VIDEO ANALYZER 4000

K874750 is an FDA 510(k) clearance for VIDEO ANALYZER 4000, manufactured by Scientific Imaging, Inc.. The device is a Class 1 Pathology device with product code IBJ cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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

FDA 510(k) Submission Details - K874750

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.

IBJ Device Classification - Class 1, General Controls

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.