I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL

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- Catalog Number : 6909

Device Description : GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

Device Description : It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and converts the them into electronic signal from which the images are constructed.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6006-15GM3

Device Description : MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedi MAW is a Management & Acquisition Workstation with 21" LCD 2Mpixel monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.

Device Class :

Duns Number: 429113525

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6907

Device Description : GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6902

Device Description : GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereo GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6501

Device Description : Giotto Image is a conventional film-screen x-ray mammographic device.

Device Class :

Duns Number: 429113525

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6702

Device Description : Giotto Image is a conventional film-screen x-ray mammographic device.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 9201-01

Device Description : Biopsy Digit SL is a medical device intended to be used for mamnmographic proced Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 9100-01

Device Description : Biopsy Digit device uses two stereo images taken by a digital solid state camera Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 6100-06M1

Device Description : It's a special table on wheels for stereotactic breast biopsy procedures with pa It's a special table on wheels for stereotactic breast biopsy procedures with patient in prone position.

Device Class : 2

Duns Number: 429113525

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1