The following data is part of a premarket notification filed by Medecom Sarl with the FDA for Medws Software (variants Medview, Meddiag, Medmammo).
| Device ID | K132684 |
| 510k Number | K132684 |
| Device Name: | MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDECOM SARL 2 RUE QUENOT Jarnac, FR 16 200 |
| Contact | Cynthia Cottereau |
| Correspondent | Cynthia Cottereau MEDECOM SARL 2 RUE QUENOT Jarnac, FR 16 200 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2014-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665587000002 | K132684 | 000 |
| 03665587000026 | K132684 | 000 |
| 03665587000033 | K132684 | 000 |
| 03665587000057 | K132684 | 000 |
| 03665587000064 | K132684 | 000 |
| 03665587000071 | K132684 | 000 |
| 03665587000088 | K132684 | 000 |
| 03665587000095 | K132684 | 000 |