Villa Sistemi Medicali S.p.A.

BUCCINASCO Milano, IT

VILLA SISTEMI MEDICALI S.P.A. appears in FDA device records in BUCCINASCO Milano, IT. FDA records list 13 510(k) clearances between 1999-01-14 and 2018-11-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 13
PMA records: 0
Recall records: 8
Registered establishments: 1

510(k) clearance history

FDA records hold 13 510(k) clearances for Villa Sistemi Medicali S.p.A. between 1999 and 2018. The busiest year on record is 1999, with 2. The most recent is 2018, with 1.

Clearances by year, as a table

510(k) clearance decisions for Villa Sistemi Medicali S.p.A., by decision year
Year	Clearances
1999	2
2000	2
2003	2
2005	1
2008	1
2009	1
2011	1
2013	1
2017	1
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K180601	Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)	OAS	Substantially Equivalent	2018-11-02
K162190	Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)	MUH	Substantially Equivalent	2017-07-06
K130109	ENDOGRAPH DC	EHD	Substantially Equivalent	2013-08-01
K111152	ROTOGRAPH EVO 3D	MUH	Substantially Equivalent	2011-07-22
K090749	ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191	EHD	Substantially Equivalent	2009-05-18
K080859	DRF 4343	JAA	Substantially Equivalent	2008-06-04
K050190	APOLLO	KXJ	Substantially Equivalent	2005-03-25
K030634	ENDOS DC	EHD	Substantially Equivalent	2003-07-21
K030185	ENDOS AC/ACP	EHD	Substantially Equivalent	2003-03-11
K002432	STRATO X	EHD	Substantially Equivalent	2000-09-01
K000412	VISION R/F TILTING TABLE	IXR	Substantially Equivalent	2000-04-24
K991310	EXPLOR-X 70	EHD	Substantially Equivalent	1999-06-18
K984524	AZTECH 70	EHD	Substantially Equivalent	1999-01-14

Registered establishments

FDA registered establishments for Villa Sistemi Medicali S.p.A., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
8021091	3002808461	VILLA SISTEMI MEDICALI S.P.A.	VIA DELLE AZALEE 3, BUCCINASCO Milano 20090 IT	2026	IXL JAA KPW KXJ MQB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0766-2020	Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.	Class II	2019-11-04	Open, Classified
Z-0765-2020	Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.	Class II	2019-11-04	Open, Classified
Z-0764-2020	Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.	Class II	2019-11-04	Open, Classified
Z-0763-2020	Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.	An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.	Class II	2019-11-04	Open, Classified
Z-1430-2017	Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures	Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.	Class II	2016-12-27	Terminated
Z-1429-2017	Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures	Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.	Class II	2016-12-27	Terminated
Z-1428-2017	Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.	Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.	Class II	2016-12-27	Terminated
Z-1427-2017	Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures	Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.	Class II	2016-12-27	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain