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

Imaging Sciences Intl., Inc. — Predicate Candidate Screening

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

56 daysmedian FDA review time

241 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061284	I-CAT SCANNER	Imaging Sciences Intl., Inc.	2006-07-03	56	2
K051980	DVT SCANNER	Imaging Sciences Intl., Inc.	2005-08-19	29	3
K041078	SURGPLAN AND PANPLAN	Imaging Sciences Intl., Inc.	2004-12-23	241	0
K001248	MULTI-PULSE 2000	Imaging Sciences Intl., Inc.	2000-05-04	16	0
K991518	PANATOME	Imaging Sciences Intl., Inc.	1999-06-18	49	0
K981466	XR-910	Imaging Sciences Intl., Inc.	1998-07-14	82	0
K931815	2000 X-RAY - TOMOGRAPHIC	Imaging Sciences Intl., Inc.	1993-08-23	137	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