The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Modification To E-scan Xq Mri System.
| Device ID | K041145 |
| 510k Number | K041145 |
| Device Name: | MODIFICATION TO E-SCAN XQ MRI SYSTEM |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-05-14 |
| Summary: | summary |