The following data is part of a premarket notification filed by Philips Digital Mammography Sweden Ab with the FDA for Philips Microdose.
| Device ID | K120255 |
| 510k Number | K120255 |
| Device Name: | PHILIPS MICRODOSE |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5 Solna, SE Se-171 41 |
| Contact | Gustav Lins |
| Correspondent | Gustav Lins PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB Smidesvagen 5 Solna, SE Se-171 41 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-04-19 |
| Summary: | summary |