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

Standard Imaging, Inc. — Predicate Candidate Screening

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

47 daysmedian FDA review time

87 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K103193	DOSEVIEW 3D	Standard Imaging, Inc.	2010-12-27	59
K082773	STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331	Standard Imaging, Inc.	2008-11-19	58
K060532	HDR 1000 PLUS WELL CHAMBER, MODEL 90008	Standard Imaging, Inc.	2006-04-11	42
K042733	STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM	Standard Imaging, Inc.	2004-11-15	45
K040688	STANDARD IMAGING E.IMRT CALCULATOR	Standard Imaging, Inc.	2004-05-11	56
K013548	STANDARD IMAGING IVB 1000 WELL CHAMBER	Standard Imaging, Inc.	2001-11-09	16
K002833	MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER	Standard Imaging, Inc.	2000-09-28	16
K001825	STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING	Standard Imaging, Inc.	2000-08-02	47
K940539	STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM	Standard Imaging, Inc.	1994-03-16	37
K922554	STANDARD IMAGING HDR 1000 ION CHAMBER	Standard Imaging, Inc.	1992-08-24	87

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