MICRODOSE SI
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
Philips Digital Mammography Sweden AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009307584 | 3009307584 | Philips Digital Mammography Sweden AB | 1 | N | 2020-04-25 | Kanalvagen 18 Upplands Vasby Stockholms lan [SE-01] SE 194 61 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 132893 | 1205599998 | K130704 | MICRODOSE SI | MUE | 2013-12-13 |
| 132893 | 1519408032 | K123995 | MICRODOSE SI | MUE | 2013-02-01 |
| 132893 | 1876867617 | K120255 | PHILIPS MICRODOSE | MUE | 2012-04-19 |
| 132893 | 1052346332 | K110025 | SECTRA MICRODOSE MAMMOGRAPHY | MUE | 2011-04-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MUE | 4 | 2013-12-13 |
PMN#
MICRODOSE SI
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
PHILIPS MICRODOSE
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
GUDID#
MicroDose SI - 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.
2016-08-31
MicroDose SI - 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.
2016-09-23
Collimator Cradle 512 asm - The collimator is intended for a larger compression height range with breasts of larger size.
2016-09-19