The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Portable X-ray System.
| Device ID | K122124 |
| 510k Number | K122124 |
| Device Name: | PORTABLE X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2013-05-16 |
| Summary: | summary |