Cleared Traditional

K032113 - ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (FDA 510(k) Clearance)

K032113 · Chroma Vision Medical Systems, Inc. · Pathology device
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Dec 2003
Decision
167d
Days
-
Risk

K032113 is an FDA 510(k) clearance for the ACIS (AUTOMATED CELLULAR IMAGING SYSTEM).

Submitted by Chroma Vision Medical Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 167 days - an extended review cycle.

This device falls under the Pathology FDA review panel. 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 Chroma Vision Medical Systems, Inc. devices

Submission Details

510(k) Number K032113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date December 23, 2003
Days to Decision 167 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
90d slower than avg
Panel avg: 77d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -