The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for Modification To E-scan Xq.
| Device ID | K032121 |
| 510k Number | K032121 |
| Device Name: | MODIFICATION TO E-SCAN XQ |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Colleen J Densmore |
| Correspondent | Colleen J Densmore ESAOTE S.P.A. 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2003-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453327 | K032121 | 000 |
| 08056304453310 | K032121 | 000 |