The following data is part of a premarket notification filed by Rolence Enterprise Inc. with the FDA for Portable X-ray System.
| Device ID | K172928 |
| 510k Number | K172928 |
| Device Name: | Portable X-ray System |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan, TW 32083 |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan, TW 32083 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04713909450628 | K172928 | 000 |
| D884XR3800 | K172928 | 000 |