The following data is part of a premarket notification filed by Tissue Differentiation Intelligence, Llc with the FDA for Sonovision Ultrasound Imaging System.
| Device ID | K192388 |
| 510k Number | K192388 |
| Device Name: | SonoVision Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Tissue Differentiation Intelligence, LLC 234 NE 4th Avenue Delray Beach, FL 33483 |
| Contact | Christian Zaal |
| Correspondent | Lorry Weaver Huffman Qserve Group, US, Inc. 303 Twin Dolphin, Suite 600 Redwood Shores, CA 94065 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001239355 | K192388 | 000 |
| 00860001239348 | K192388 | 000 |