The following data is part of a premarket notification filed by Emagine Solutions Technology, Llc with the FDA for Vistascan Usb Ultrasound Imaging System.
| Device ID | K192170 |
| 510k Number | K192170 |
| Device Name: | VistaScan USB Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Emagine Solutions Technology, LLC 9040 S. Rita Road, Suite 1270 Tucson, AZ 85747 |
| Contact | Courtney Williams |
| Correspondent | Michelle Lott Lean RAQA, LLC 12602 N Summer Wind Dr Marana, AZ 85658 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2020-01-23 |