The following data is part of a premarket notification filed by Echo Pixel Inc. with the FDA for Echo True 3d Viewer.
| Device ID | K142107 |
| 510k Number | K142107 |
| Device Name: | ECHO TRUE 3D VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | ECHO PIXEL INC. 2490 HOSPITAL DR. 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2015-01-21 |
| Summary: | summary |