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 | K192303 |
| 510k Number | K192303 |
| Device Name: | ExactVu High Resolution Micro-Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Exact Imaging Inc. 7676 Woodbine Avenue Unit 15 Markham, CA L3r 2n2 |
| Contact | Sam Rajkumar |
| Correspondent | Prithul Bom 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2019-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10628055481116 | K192303 | 000 |