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

Icad, Inc. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time

269 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240417	ProFound Detection (V4.0)	Icad, Inc.	2024-11-08	269	0
K211506	PowerLook Density Assessment V4.0	Icad, Inc.	2021-07-12	59	0
K203822	ProFound AI Software V3.0	Icad, Inc.	2021-03-12	73	0
K191994	ProFound AI Software V2.1	Icad, Inc.	2019-10-04	70	0
K182373	PowerLook Tomo Detection V2 Software	Icad, Inc.	2018-12-06	97	0
K180125	PowerLook Density Assessment Software	Icad, Inc.	2018-04-05	79	0
K153570	Axxent Electronic Brachytherapy System Model 110 XP 1200	Icad, Inc.	2016-02-25	73	0
K141343	AXXENT CERVICAL APPLICATOR	Icad, Inc.	2014-09-05	107	0
K123442	XOFT AXXENT CERVICAL APPLICATORS	Icad, Inc.	2013-02-27	111	0
K122951	XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110	Icad, Inc.	2013-01-17	114	0
K121517	VERSAVUE ENTERPRISE SUITE	Icad, Inc.	2012-07-20	59	1
K091529	ICAD VERALOOK CTC CAD SOFTWARE	Icad, Inc.	2010-08-04	439	0
K090223	ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024	Icad, Inc.	2009-03-31	60	1
K042697	SECOND LOOK VIEWER	Icad, Inc.	2004-11-19	50	0

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