The following data is part of a premarket notification filed by Esaote, S.p.a. with the FDA for G-scan-model 9800020000, E-scan Model 9800010000 And E-scan Xq-models-9800010011/9800010005,9800010009/9800010004.
| Device ID | K060956 |
| 510k Number | K060956 |
| Device Name: | G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453303 | K060956 | 000 |
| 08056304453297 | K060956 | 000 |
| 08056304453280 | K060956 | 000 |
| 08056304453273 | K060956 | 000 |
| 08056304453266 | K060956 | 000 |
| 08056304453259 | K060956 | 000 |
| 08056304453242 | K060956 | 000 |
| 08056304453235 | K060956 | 000 |