The following data is part of a premarket notification filed by Nanoray Co., Ltd. with the FDA for Portable Dental X-ray (nr-f350, Cs 2400p, Cs 2300p, R2 Port-x).
| Device ID | K201800 |
| 510k Number | K201800 |
| Device Name: | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | NANORAY Co., Ltd. #401, #402, #403, #408, #409, 76, Dongnae-ro, Dong-gu Daegu, KR 41061 |
| Contact | Won Hyun Sung |
| Correspondent | Sanglok Lee Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu, KR 08507 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2020-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800072313624 | K201800 | 000 |
| 08800072313525 | K201800 | 000 |
| 08800072313426 | K201800 | 000 |
| 08800072313327 | K201800 | 000 |
| 08800072313228 | K201800 | 000 |
| 08800072313112 | K201800 | 000 |