The following data is part of a premarket notification filed by Echopixel Inc. with the FDA for True 3d Viewer Software.
| Device ID | K170167 |
| 510k Number | K170167 |
| Device Name: | True 3D Viewer Software |
| Classification | System, Image Processing, Radiological |
| Applicant | EchoPixel Inc. 2490 Hospital Drive, Suite 310 Mountain View, CA 94040 |
| Contact | Sergio Aguirre |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-01-19 |
| Decision Date | 2017-03-03 |
| Summary: | summary |