The following data is part of a premarket notification filed by Vidistar, Llc with the FDA for Vidistar Heartview.
| Device ID | K152822 |
| 510k Number | K152822 |
| Device Name: | VidiStar HeartView |
| Classification | System, Image Processing, Radiological |
| Applicant | VIDISTAR, LLC PO BOX 8539 Greenville, SC 29604 |
| Contact | Craig Walker |
| Correspondent | Kathryn Becker Translational Science Solutions LLC 92 Hasell Street #401 Charleston, SC 29401 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2015-11-25 |
| Summary: | summary |