The following data is part of a premarket notification filed by Televere Systems with the FDA for Televere Digital Imaging System.
| Device ID | K170975 |
| 510k Number | K170975 |
| Device Name: | Televere Digital Imaging System |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Televere Systems 1160 Cavalier Rd Arnold, MD 21012 |
| Contact | Randell Quaal |
| Correspondent | Robert Bakin Technology & Business Law Advisors, LLC 1244 Capuchino Ave Burlingame, CA 94010 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-05-01 |
| Summary: | summary |