Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Eigen — Predicate Candidate Screening

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

79 daysmedian FDA review time

349 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K222222	Artemis, Artemis TPO, Artemis MX	Eigen	2023-10-12	444
K173744	ProFuse CAD	Eigen	2018-11-21	349
K162474	Artemis	Eigen	2016-10-21	45
K063846	EIGEN DSA 2000	Eigen	2007-01-26	30
K933115	DIGITAL DISK RECORDER	Eigen	1994-04-07	286
K924164	DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT	Eigen	1992-11-23	96
K923585	DIGITAL FLUORO STORE	Eigen	1992-10-21	93
K913012	DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES	Eigen	1991-09-23	77
K905111	DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES	Eigen	1991-01-25	73
K903821	PSC-1 W/OTHER NUMERICAL	Eigen	1990-11-07	79
K902927	DIGITAL PHOTOSPOT	Eigen	1990-08-03	31
K901956	DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)	Eigen	1990-07-02	62
K890745	SC-1000 WITH SUFFIXES (SCAN CONVERTER)	Eigen	1989-03-14	29
K882175	HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP	Eigen	1988-08-19	87
K882176	VTR-12	Eigen	1988-08-11	79
K882184	HR-1000 W/SUFFIXES (B,C OR D)	Eigen	1988-06-28	35

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