Cytoscan(r) Dx

DEN130018 is the FDA 510(k) clearance record for CYTOSCAN(R) DX, a class II device, cleared for Affymetrix, Inc. on 2014-01-17 under FDA product code PFX (System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection). FDA's definition for product code PFX reads: "A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is...". FDA records list 4 510(k) clearances for Affymetrix, Inc., from 2004-12-23 to 2014-01-17. As of 2026-09-10, FDA records show no recalls naming DEN130018.