The following data is part of a premarket notification filed by Ellex, Inc. with the FDA for Ellex Innovative Imaging Eye Cubed V4.
| Device ID | K083061 |
| 510k Number | K083061 |
| Device Name: | ELLEX INNOVATIVE IMAGING EYE CUBED V4 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ELLEX, INC. 9940 BUSINESS PARK DR. SUITE 165 Sacramento, CA 95827 |
| Contact | Tom Davis |
| Correspondent | Tom Davis ELLEX, INC. 9940 BUSINESS PARK DR. SUITE 165 Sacramento, CA 95827 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2009-01-09 |