The following data is part of a premarket notification filed by Echopixel, Inc. with the FDA for True 3d Viewer.
| Device ID | K201365 |
| 510k Number | K201365 |
| Device Name: | True 3D Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | EchoPixel, Inc. 4677 Old Ironsides Drive, Suite 445 Santa Clara, CA 95054 |
| Contact | Michael Gabler |
| Correspondent | Sheila Pickering Sheila Pickering Consulting Group 2081 Longden Circle Los Altos, CA 94024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-22 |
| Decision Date | 2020-07-17 |