The following data is part of a premarket notification filed by Echopixel Inc. with the FDA for True 3d Viewer Software.
| Device ID | K193149 |
| 510k Number | K193149 |
| Device Name: | True 3D Viewer Software |
| Classification | System, Image Processing, Radiological |
| Applicant | EchoPixel Inc. 4677 Old Ironsides Suite 445 Santa Clara, CA 95054 |
| Contact | Michael Gabler |
| Correspondent | Prithul Bom 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2019-12-27 |