The following data is part of a premarket notification filed by Jpi America, Inc. with the FDA for Ajex 9015/135h Portable X-ray.
| Device ID | K052341 |
| 510k Number | K052341 |
| Device Name: | AJEX 9015/135H PORTABLE X-RAY |
| Classification | System, X-ray, Mobile |
| Applicant | JPI AMERICA, INC. 141 CENTRAL AVE., SUITE A Farmingdale, NY 11735 -6903 |
| Contact | Abe Elgohary |
| Correspondent | Abe Elgohary JPI AMERICA, INC. 141 CENTRAL AVE., SUITE A Farmingdale, NY 11735 -6903 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-10-07 |
| Summary: | summary |