The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Planmed Nuance Excel.
| Device ID | K111361 |
| 510k Number | K111361 |
| Device Name: | PLANMED NUANCE EXCEL |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | PLANMECA USA, INC. 100 N. GARY AVE. SUITE A Roselle, IL 60172 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMECA USA, INC. 100 N. GARY AVE. SUITE A Roselle, IL 60172 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-09-23 |
| Summary: | summary |