K201800 is an FDA 510(k) clearance for the Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X). This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Nanoray Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 28, 2020, 181 days after receiving the submission on June 30, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K201800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2020 |
| Decision Date | December 28, 2020 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |