The following data is part of a premarket notification filed by Pointnix Co., Ltd with the FDA for Point 500 Hd Point500c Hd.
| Device ID | K121800 |
| 510k Number | K121800 |
| Device Name: | POINT 500 HD POINT500C HD |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | POINTNIX CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah POINTNIX CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-19 |
| Decision Date | 2013-01-24 |
| Summary: | summary |