K213942 is an FDA 510(k) clearance for the Esteya. This device is classified as a System, Therapeutic, X-ray (Class II - Special Controls, product code JAD).
Submitted by Nucletron B.V. (Veenendaal, NL). The FDA issued a Cleared decision on January 11, 2022, 25 days after receiving the submission on December 17, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5900.
| 510(k) Number | K213942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2021 |
| Decision Date | January 11, 2022 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAD - System, Therapeutic, X-ray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5900 |