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

NTH — Predicate Candidate Screening

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

199 daysmedian FDA review time

415 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K130775	DUET SYSTEM	Bioview , Ltd.	2014-05-09	415
K122554	GENASIS SCANVIEW SYSTEM	Applied Spectral Imaging , Ltd.	2013-02-07	170
K110345	SCANVIEW SYSTEM	Applied Spectral Imaging	2011-10-19	257
K101291	SCANVIEW HER2/NEU FISH SYSTEM	Applied Spectral Imaging , Ltd.	2010-11-23	200
K080909	ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000	Ikonisys, Inc.	2008-10-17	199
K043519	ARIOL HER-2/NEU FISH	Applied Imaging Corp.	2005-04-25	126
K042542	CYTOVISION FOR CEP XY	Applied Imaging Corp.	2005-01-10	112
DEN040010	VYSIS AUTOVYSION SYSTEM	Vysis	2004-12-13	61

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