The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Mri Dynamic Analysis Plus.
| Device ID | K153039 |
| 510k Number | K153039 |
| Device Name: | MRI Dynamic Analysis Plus |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Esaote S.p.A. Via Siffredi 58 Genovo, IT 16153 |
| Contact | Donatella Ragghianti |
| Correspondent | Allison Scott NAVIGANT CONSULTING, INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis, IN 46268 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-01-08 |
| Summary: | summary |