The following data is part of a premarket notification filed by Kinepict Health Ltd with the FDA for Kinepict Medical Imaging Tool 4.0.
| Device ID | K202056 |
| 510k Number | K202056 |
| Device Name: | Kinepict Medical Imaging Tool 4.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Kinepict Health Ltd Kelta K Z Budakeszi, HU 2092 |
| Contact | Lilla Strobel |
| Correspondent | Lilla Strobel Kinepict Health Ltd Kelta K Z Budakeszi, HU 2092 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-24 |
| Decision Date | 2021-09-10 |