Cleared Traditional

K032113 - ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

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

FDA 510(k) Submission Details - K032113

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.

NOT Device Classification - Class ,

Product Code NOT
Device Class -