The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Panoura X-era Pf/nf/mf.
| Device ID | K182198 |
| 510k Number | K182198 |
| Device Name: | Panoura X-ERA PF/NF/MF |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi Sumida-ku, JP 130-8516 |
| Contact | Hidenori Watanabe |
| Correspondent | Hidenori Watanabe The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi Sumida-ku, JP 130-8516 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-14 |
| Decision Date | 2019-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547497759531 | K182198 | 000 |
| 04547497759524 | K182198 | 000 |
| 04547497759517 | K182198 | 000 |
| 04547497759470 | K182198 | 000 |
| 04547497759463 | K182198 | 000 |
| 04547497759456 | K182198 | 000 |