The following data is part of a premarket notification filed by Aspenstate Inc with the FDA for Apx-24 Portable X-ray System.
| Device ID | K220678 |
| 510k Number | K220678 |
| Device Name: | APX-24 Portable X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Aspenstate INC 801 North Jupiter Rd, Suite 200 Plano, TX 75074 |
| Contact | Albert Kim |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St, Suite 610 Houston, TX 77054 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-08 |
| Decision Date | 2022-03-31 |