The following data is part of a premarket notification filed by Takara Belmont Corporation with the FDA for Bel-cypher Pro.
| Device ID | K163175 |
| 510k Number | K163175 |
| Device Name: | Bel-Cypher Pro |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Takara Belmont Corporation 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Osaka, JP 542-0083 |
| Contact | Toshinori Kiyomatsu |
| Correspondent | Robert Schiff Schiff & Company, Inc. 1120 Bloomfield Ave. West Caldwell, NJ 07006 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-03-20 |
| Summary: | summary |