The following data is part of a premarket notification filed by Exact Imaging with the FDA for Exactvu High Resolution Micro-ultrasound System.
| Device ID | K162972 |
| 510k Number | K162972 |
| Device Name: | ExactVu High Resolution Micro-Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Exact Imaging 7676 Woodbine Avenue Unit 15 Markham, CA L3r 2n2 |
| Contact | Karina Torres |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-10-25 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20628055481076 | K162972 | 000 |
| 00628055481041 | K162972 | 000 |
| 00628055481034 | K162972 | 000 |
| 00628055481027 | K162972 | 000 |
| 00628055481010 | K162972 | 000 |