Cleared Traditional

K050236 - FISHVIEW (FDA 510(k) Clearance)

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

K050236 · Applied Spectral Imaging , Ltd. · Pathology device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
147d
Days
Class 2
Risk

K050236 is an FDA 510(k) clearance for the FISHVIEW. Classified as Analyzer, Chromosome, Automated (product code LNJ), Class II - Special Controls.

Submitted by Applied Spectral Imaging , Ltd. (Haifa, IL). The FDA issued a Cleared decision on June 27, 2005 after a review of 147 days - within the typical 510(k) review window.

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: 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 Applied Spectral Imaging , Ltd. devices

Submission Details

510(k) Number K050236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2005
Decision Date June 27, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 77d · This submission: 147d
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.