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

Image Analysis, Inc. — Predicate Candidate Screening

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

109 daysmedian FDA review time

428 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K040782	N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.	Image Analysis, Inc.	2004-07-13	109
K031991	DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS	Image Analysis, Inc.	2003-07-30	33
K992246	QCT BONE MINERAL ANALYSIS SOFTWARE	Image Analysis, Inc.	1999-09-03	59
K952060	QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-	Image Analysis, Inc.	1995-06-05	34
K941127	QCT-BONE MINERAL ANALYSIS SOFTWARE	Image Analysis, Inc.	1995-05-11	428
K941126	QCT-BONE MINERAL ANALYSIS PHANTOM	Image Analysis, Inc.	1995-05-03	420
K891931	QCT-LUNG NODULE (TM) ANALYSIS PACKAGE	Image Analysis, Inc.	1989-05-18	51
K852509	QCT-BONE MINERAL PHANTOM	Image Analysis, Inc.	1985-10-18	128
K852510	COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS	Image Analysis, Inc.	1985-10-18	128

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