The following data is part of a premarket notification filed by Genoray Co., Ltd. with the FDA for Portable X-ray System, Model Port-x Ii.
| Device ID | K063121 |
| 510k Number | K063121 |
| Device Name: | PORTABLE X-RAY SYSTEM, MODEL PORT-X II |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | GENORAY CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-12 |
| Decision Date | 2007-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809244061035 | K063121 | 000 |