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

Pie Medical Imaging BV · Predicate Candidate Screening

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

106 daysmedian FDA review time

265 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250330	3mensio Workstation	Pie Medical Imaging BV	2025-11-03	271	1
K232147	CAAS Workstation	Pie Medical Imaging BV	2024-04-09	265	0
K232007	CAAS MR Solutions	Pie Medical Imaging BV	2024-02-01	210	0
K212376	Caas Qardia	Pie Medical Imaging BV	2022-05-16	290	0
K181825	CAAS MR Solutions	Pie Medical Imaging BV	2018-12-04	148	0
K180019	CAAS Workstation	Pie Medical Imaging BV	2018-05-03	121	0
K162376	CAAS MR 4D Flow	Pie Medical Imaging BV	2016-12-08	106	0
K162112	CAAS MRV	Pie Medical Imaging BV	2016-09-21	54	0
K153736	3mensio Workstation	Pie Medical Imaging BV	2016-05-27	151	1
K151780	CAAS Workstation	Pie Medical Imaging BV	2016-03-11	254	0
K143044	CAAS A-Valve	Pie Medical Imaging BV	2015-02-06	107	0
K123970	CAAS INTRAVASCULAR	Pie Medical Imaging BV	2013-02-06	42	0
K120367	3MENSIO WORKSTATION	Pie Medical Imaging BV	2012-04-17	71	0
K113076	CAAS A-VALVE	Pie Medical Imaging BV	2012-01-30	105	0
K100292	CAAS QVA 3D, CAAS QCA 3D	Pie Medical Imaging BV	2010-04-30	87	0
K090155	CAAS MR FLOW 1.0	Pie Medical Imaging BV	2009-05-22	120	0
K063344	CAAS QCA 3D	Pie Medical Imaging BV	2006-11-28	22	0
K060941	CAAS MRV VERSION 3.0	Pie Medical Imaging BV	2006-04-19	13	0
K052988	CAAS	Pie Medical Imaging BV	2005-12-30	67	0
K041682	CAAS MRV	Pie Medical Imaging BV	2004-07-27	36	0
K033920	CAAS II RVA	Pie Medical Imaging BV	2004-03-17	90	0
K021495	QIVA	Pie Medical Imaging BV	2002-10-01	145	0
K012475	CAAS II QVA	Pie Medical Imaging BV	2001-10-24	83	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