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

Eos Imaging — Predicate Candidate Screening

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

117 daysmedian FDA review time

320 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251078	AutoDensity	Eos Imaging	2025-11-14	220	0
K251747	VEA Align; spineEOS	Eos Imaging	2025-08-15	70	0
K233920	EOSedge	Eos Imaging	2024-08-06	237	0
K240582	VEA Align; spineEOS	Eos Imaging	2024-06-25	116	0
K231917	VEA Align	Eos Imaging	2024-01-05	190	0
K232086	spineEOS	Eos Imaging	2023-10-24	103	0
K202394	EOSedge	Eos Imaging	2020-09-16	26	0
K192079	EOSedge	Eos Imaging	2019-11-27	117	0
K172346	sterEOS Workstation	Eos Imaging	2018-06-19	320	0
K152788	EOS System	Eos Imaging	2015-10-21	26	0
K142773	EOS System	Eos Imaging	2015-01-22	119	0
K141137	STEREOS WORKSTATION	Eos Imaging	2014-09-15	137	0
K123740	EOS	Eos Imaging	2013-02-22	79	1
K113344	STEREOS WORKSTATION	Eos Imaging	2012-11-16	368	0
K120721	EOS	Eos Imaging	2012-04-06	29	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