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

Holder, Radiographic Cassette, Wall-Mounted (IXY) (4) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (3) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (2) Table, Radiologic (KXJ) (2) System, X-Ray, Angiographic (IZI) (1) System, X-Ray, Tomographic (IZF) (1)

Premarket Exempt

Clear

Discovery RF180 - 08054890480109 Catalog Number :

Device Description : The Discovery RF180 is a floor-mounted radiographic, fluoroscopic and linear tom The Discovery RF180 is a floor-mounted radiographic, fluoroscopic and linear tomographic system that consists of a 90/90 universal remote-controlled table with variable height, an R&F panel connected to a digital system and a voltage generator.

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480116 Catalog Number :

Device Description : It is an R&F remote controlled table, that can be used as a traditional R&F remo It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table or it is possible to perform examination with detector directly in contact with the patient by using in combination the optional: Overhead Tube Suspension, Wall Stand and 2nd Wi-Fi detector.

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : KXJ

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480123 Catalog Number :

Device Description : It's a system for acquiring digital images in fluoroscopy and radiography modes It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF allows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : JAA

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480130 Catalog Number :

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

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IXY

Prescription Use : Yes

Device Count : 1

THALES - 08054890480147 Catalog Number :

Device Description : The detector is suitable for acquiring digital images in radiography modes. It a The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

THALES - 08054890480154 Catalog Number :

Device Class : 2

Duns Number: 428658934

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480161 Catalog Number :

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

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IXY

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480178 Catalog Number :

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

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IXY

Prescription Use : Yes

Device Count : 1

Discovery RF180 - 08054890480185 Catalog Number :

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

Device Class : 1

Duns Number: 428658934

Premarket Exempt : No

Product Code : IXY

Prescription Use : Yes

Device Count : 1

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