The following data is part of a premarket notification filed by Thirona Corporation with the FDA for Lungq Software.
| Device ID | K173821 |
| 510k Number | K173821 |
| Device Name: | LungQ Software |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Thirona Corporation Toernooiveld 300 Nijmegen, NL 6525 Ec |
| Contact | Eva Van Rikxoort |
| Correspondent | Jean-paul Charbonnier Thirona Corporation Toernooiveld 300 Nijmegen, NL 6525 Ec |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-06-05 |
| Summary: | summary |