Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Toshiba Medical Systems Corporation, Japan · Predicate Candidate Screening

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

49 daysmedian FDA review time

336 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172878	Vantage Titan 3T, MRT-3010/A7, M-Power GX	Toshiba Medical Systems Corporation, Japan	2017-11-17	57	0
K133324	SURESUBTRACTION LUNG	Toshiba Medical Systems Corporation, Japan	2014-09-05	311	0
K121910	OCTAVE SPEEDER HEAD	Toshiba Medical Systems Corporation, Japan	2012-08-17	49	0
K121911	OCTAVE SPEEDER SPINE	Toshiba Medical Systems Corporation, Japan	2012-08-17	49	0
K121577	APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM	Toshiba Medical Systems Corporation, Japan	2012-06-22	23	0
K120546	AQUILION PREMIUM	Toshiba Medical Systems Corporation, Japan	2012-06-13	111	2
K112054	INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V	Toshiba Medical Systems Corporation, Japan	2011-08-05	17	0
K102489	VANTAGE TITAN 3T	Toshiba Medical Systems Corporation, Japan	2011-08-02	336	1
K103645	APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM	Toshiba Medical Systems Corporation, Japan	2011-01-12	30	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