The following data is part of a premarket notification filed by Vidistar, Llc with the FDA for Vidistar Pacs & Dicom Viewer Software Server Software System, Heart View, Standalone Viewer.
| Device ID | K083910 |
| 510k Number | K083910 |
| Device Name: | VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | VIDISTAR, LLC PO BOX 8539 Greenville, SC 29604 |
| Contact | Craig Walker |
| Correspondent | Craig Walker VIDISTAR, LLC PO BOX 8539 Greenville, SC 29604 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-30 |
| Decision Date | 2009-04-15 |
| Summary: | summary |