The following data is part of a premarket notification filed by Esaote Europe B.v. with the FDA for Imt.lab Software.
| Device ID | K062598 |
| 510k Number | K062598 |
| Device Name: | IMT.LAB SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham ESAOTE EUROPE B.V. 11460 N. MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-10-31 |
| Summary: | summary |