Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NOT — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

167 daysmedian FDA review time
519 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260755OptraSCAN SystemOptrascan, Inc.2026-07-021150
K141109APERIO EPATHOLOGY EIHC IVD SYSTEMLeica Biosystems Imaging, Inc.2014-07-29911
K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.2013-09-065190
K121350VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.2012-06-01280
K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.2012-02-222450
K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.2011-10-121320
K080564SCANSCOPE XT SYSTEMAperio Technologies2009-08-145330
K080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & Bioimagene, Inc.2009-02-043090
K071128SCANSCOPE XT SYSTEMAperio Technologies2007-10-101700
K062756PATHIAM IMAGING SOFTWARE FOR HER2/NEUBioimagene, Inc.2007-02-201590
K051282VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEUTripath Imaging, Inc.2005-08-16910
K031715ARIOL HER-2/NEU IHCApplied Imaging Corp.2004-01-082200
K032113ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)Chroma Vision Medical Systems, Inc.2003-12-231670

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda