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

Villa Sistemi Medicali S.P.A. · Predicate Candidate Screening

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

69 daysmedian FDA review time

240 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K180601	Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali)	Villa Sistemi Medicali S.P.A.	2018-11-02	240	0
K162190	Rotograph Prime (under trade mark Villa Sistemi Medicali), I	Villa Sistemi Medicali S.P.A.	2017-07-06	336	0
K130109	ENDOGRAPH DC	Villa Sistemi Medicali S.P.A.	2013-08-01	197	0
K111152	ROTOGRAPH EVO 3D	Villa Sistemi Medicali S.P.A.	2011-07-22	88	1
K090749	ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307X	Villa Sistemi Medicali S.P.A.	2009-05-18	59	0
K080859	DRF 4343	Villa Sistemi Medicali S.P.A.	2008-06-04	69	0
K050190	APOLLO	Villa Sistemi Medicali S.P.A.	2005-03-25	57	3
K030634	ENDOS DC	Villa Sistemi Medicali S.P.A.	2003-07-21	144	0
K030185	ENDOS AC/ACP	Villa Sistemi Medicali S.P.A.	2003-03-11	49	0
K002432	STRATO X	Villa Sistemi Medicali S.P.A.	2000-09-01	24	0
K000412	VISION R/F TILTING TABLE	Villa Sistemi Medicali S.P.A.	2000-04-24	76	0
K991310	EXPLOR-X 70	Villa Sistemi Medicali S.P.A.	1999-06-18	63	0
K984524	AZTECH 70	Villa Sistemi Medicali S.P.A.	1999-01-14	24	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