The following data is part of a premarket notification filed by Rolence Enterprise Inc. with the FDA for Rsx 1000.
| Device ID | K202369 |
| 510k Number | K202369 |
| Device Name: | RSX 1000 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan, TW 32083 |
| Contact | Ben Chang |
| Correspondent | Ben Chang Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan, TW 32083 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2021-09-15 |