MICRODOSE SI
Full Field Digital, System, X-ray, Mammographic
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB
The following data is part of a premarket notification filed by Philips Digital Mammography Sweden Ab with the FDA for Microdose Si.
Pre-market Notification Details
| Device ID | K130704 |
| 510k Number | K130704 |
| Device Name: | MICRODOSE SI |
| 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 | 2013-03-15 |
| Decision Date | 2013-12-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838081093 | K130704 | 000 |
| 00884838071001 | K130704 | 000 |
| 00884838070943 | K130704 | 000 |
Trademark Results [MICRODOSE SI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICRODOSE SI 79131247 4661406 Live/Registered |
Koninklijke Philips N.V. 2013-04-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.