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

Hitachi Medical Corp. · Predicate Candidate Screening

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

84 daysmedian FDA review time

166 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073310	OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID	Hitachi Medical Corp.	2008-01-18	56	0
K061608	MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER	Hitachi Medical Corp.	2006-11-22	166	0
K053258	EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER	Hitachi Medical Corp.	2005-12-09	17	0
K042501	ETG-4000 OPTICAL TOPOGRAPHY SYSTEM	Hitachi Medical Corp.	2004-10-12	28	0
K013722	MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER	Hitachi Medical Corp.	2002-02-11	94	1
K013723	MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER	Hitachi Medical Corp.	2002-02-06	89	2
K012239	MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-	Hitachi Medical Corp.	2001-08-10	24	0
K011252	EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYST	Hitachi Medical Corp.	2001-05-30	36	0
K926209	EUB-555	Hitachi Medical Corp.	1994-06-03	541	0
K910268	TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T	Hitachi Medical Corp.	1991-04-15	90	0
K827377	MODEL LS 3000 LINEAR SCANNER	Hitachi Medical Corp.	1982-07-13	84	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