The following data is part of a premarket notification filed by Exact Imaging, Inc. with the FDA for Exactvu High Resolution Micro-ultrasound System.
| Device ID | K190995 |
| 510k Number | K190995 |
| Device Name: | ExactVu High Resolution Micro-Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Exact Imaging, Inc. 7676 Woodbine Ave., Unit 15 Markham, CA L3r 2n2 |
| Contact | Randy Aucoin |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055481096 | K190995 | 000 |