GENERAL MEDICAL MERATE SPA

Address:VIA PARTIGIANI, 25,SERIATE, BERGAMO,IT

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (5) Table, Radiologic (KXJ) (3) Tube Mount, X-Ray, Diagnostic (IYB) (2) System, X-Ray, Tomographic (IZF) (1) System, X-Ray, Mobile (IZL) (1) System, X-Ray, Angiographic (IZI) (1) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1)

Premarket Exempt

No

Clear

OPERA SWING - 08054890480000 Catalog Number :

Device Description : The Opera Swing is an x-ray diagnostic system and is indicated for performing ge

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

OPERA SWING - 08054890480017 Catalog Number :

Device Description : The device is a R&F remote tilting table which allows the execution of longitudi

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480024 Catalog Number :

Device Description : The ceiling suspension is a radiographic X-ray tube suspension device that allow

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IYB

Prescription Use : Yes

Device Count : 1

OPERA SWING - 08054890480031 Catalog Number :

Device Description : The device is a stretcher in carbon fiber and it is raised via an hydraulic pist

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

OPERA SWING - 08054890480048 Catalog Number :

Device Description : It's a system for acquiring digital images in fluoroscopy and radiography modes

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

CLISIS SYSTEMS - 08054890480055 Catalog Number :

Device Description : The CLISIS SYSTEMS is a floor-mounted radiographic, fluoroscopic and linear tomo

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : KXJ, MQB, IZI, JAA, IZF

Prescription Use : Yes

Device Count : 1

CLISIS SYSTEMS - 08054890480062 Catalog Number :

Device Description : It is an R&F remote controlled table, that can be used as a traditional R&F remo

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

CLISIS SYSTEMS - 08054890480079 Catalog Number :

Device Description : It's a system for acquiring digital images in fluoroscopy and radiography modes

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

CLISIS SYSTEMS - 08054890480086 Catalog Number :

Device Description : The wall bucky stand is used to perform exposures on the potter-bucky.

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

CLISIS SYSTEMS - 08054890480093 Catalog Number :

Device Description : The ceiling suspension is a radiographic X-ray tube suspension device that allow

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IYB

Prescription Use : Yes

Device Count : 1

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