The following data is part of a premarket notification filed by Viztek Llc with the FDA for Exa.
| Device ID | K142919 |
| 510k Number | K142919 |
| Device Name: | EXA |
| Classification | System, Image Processing, Radiological |
| Applicant | Viztek LLC 6950 Philips Hwy Jacksonville, FL 32216 |
| Contact | Josip Cermin |
| Correspondent | Daniel Kamm, P.e. Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-08 |
| Decision Date | 2014-12-16 |
| Summary: | summary |