The following data is part of a premarket notification filed by Cruxell Corp. with the FDA for Cruxview.
| Device ID | K211317 |
| 510k Number | K211317 |
| Device Name: | CRUXVIEW |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | CRUXELL Corp. 405, Migun Techno World II, 187, Techno 2-ro Yuseong-gu Daejeon, KR 34025 |
| Contact | Boeun Bang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-07-29 |