Cleared Traditional

K864955 - CYTOSCAN (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864955 · Image Recognition Systems , Ltd. · Pathology device
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Mar 1987
Decision
88d
Days
Class 2
Risk

K864955 is an FDA 510(k) clearance for the CYTOSCAN. Classified as Analyzer, Chromosome, Automated (product code LNJ), Class II - Special Controls.

Submitted by Image Recognition Systems , Ltd. (Warrington, Cheshire, GB). The FDA issued a Cleared decision on March 16, 1987 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5260 - 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 Image Recognition Systems , Ltd. devices

Submission Details

510(k) Number K864955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1986
Decision Date March 16, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 77d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNJ Analyzer, Chromosome, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.