Cleared Traditional

K874207 - THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (FDA 510(k) Clearance)

Class I Pathology device.

K874207 · Intl. Remote Imaging Systems · Pathology device
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Jan 1988
Decision
82d
Days
Class 1
Risk

K874207 is an FDA 510(k) clearance for the THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION. Classified as Light, Microscope (product code IBJ), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl. Remote Imaging Systems devices

Submission Details

510(k) Number K874207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date January 05, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 77d · This submission: 82d
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.