The following data is part of a premarket notification filed by Soyee Product, Inc. with the FDA for Soyee Portable X-ray Unit, Model Sy-hf-110.
| Device ID | K070634 |
| 510k Number | K070634 |
| Device Name: | SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 |
| Classification | System, X-ray, Mobile |
| Applicant | SOYEE PRODUCT, INC. 30 NORTHPORT RD. Sound Beach, NY 11789 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch SOYEE PRODUCT, INC. 30 NORTHPORT RD. Sound Beach, NY 11789 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-07 |
| Decision Date | 2007-07-11 |