The following data is part of a premarket notification filed by Imacor Inc. with the FDA for Imacor Zura Evo Imaging System.
| Device ID | K142054 |
| 510k Number | K142054 |
| Device Name: | IMACOR ZURA EVO IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | IMACOR INC. 839 STEWART AVE. STE 3 Garden City, NY 11530 |
| Contact | James W Monroe |
| Correspondent | James W Monroe IMACOR INC. 839 STEWART AVE. STE 3 Garden City, NY 11530 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2014-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861589000108 | K142054 | 000 |