Cleared Traditional

K823040 - PATHOLOGY INSTRUMENTATION & ACCESSORIES (FDA 510(k) Clearance)

Class I Pathology device.

K823040 · Iris Remote Imaging Systems · Pathology device
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Jan 1983
Decision
92d
Days
Class 1
Risk

K823040 is an FDA 510(k) clearance for the PATHOLOGY INSTRUMENTATION & ACCESSORIES. Classified as Light, Microscope (product code IBJ), Class I - General Controls.

Submitted by Iris Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 92 days - within the typical 510(k) review window.

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 Iris Remote Imaging Systems devices

Submission Details

510(k) Number K823040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1982
Decision Date January 14, 1983
Days to Decision 92 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 77d · This submission: 92d
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.