The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for Dynamic Mri Software Option For C-scan, E-scan Xq And E-scan Opera.
| Device ID | K061429 |
| 510k Number | K061429 |
| Device Name: | DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE, S.P.A. 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-23 |
| Decision Date | 2006-07-25 |
| Summary: | summary |