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 |