Philips Digital Mammography Sweden AB

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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

Full field digital,system,x-ray,mammographic (MUE) (2) Collimator, automatic, radiographic (IZW) (1)

Premarket Exempt

Clear

MicroDose SI - 00884838070943 Catalog Number : 714048

Device Description : Philips MicroDose Mammography SI L50 is intended to produce radiographic images Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems.

Device Class : 2

Duns Number: 632899233

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

MicroDose SI - 00884838071001 Catalog Number : 714248

Device Description : Philips MicroDose SI (Model: L50) is intended to produce radiographic images of Philips MicroDose SI (Model: L50) is intended to produce radiographic images of the human breast for the purpose of diagnostic and screening mammography. The system is intended to be used in the same clinical applications as traditional film-based mammography systems.

Device Class : 2

Duns Number: 632899233

Premarket Exempt : No

Product Code : MUE

Prescription Use : Yes

Device Count : 1

Collimator Cradle 512 asm - 00884838081093 Catalog Number :

Device Description : The collimator is intended for a larger compression height range with breasts of The collimator is intended for a larger compression height range with breasts of larger size.

Device Class : 2

Duns Number: 632899233

Premarket Exempt : No

Product Code : IZW

Prescription Use : Yes

Device Count : 1

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