The following data is part of a premarket notification filed by Pie Medical with the FDA for Imt.lab.
| Device ID | K043360 |
| 510k Number | K043360 |
| Device Name: | IMT.LAB |
| Classification | System, Image Processing, Radiological |
| Applicant | PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Contact | Carri Graham |
| Correspondent | Carri Graham PIE MEDICAL 7992 CASTLEWAY DRIVE Indianapolis, IN 46250 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-07 |
| Decision Date | 2005-01-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMT.LAB 78678122 3232531 Dead/Cancelled |
Biosound Esaote, Inc. 2005-07-26 |