The following data is part of a premarket notification filed by Huestis Machine Corporation with the FDA for Mx40 Mobile Digital X-ray System.
| Device ID | K181874 |
| 510k Number | K181874 |
| Device Name: | MX40 Mobile Digital X-ray System |
| Classification | System, X-ray, Mobile |
| Applicant | Huestis Machine Corporation 68 Buttonwood Street Bristol, RI 02809 |
| Contact | Frederick M. Correira |
| Correspondent | Frederick M. Correira Huestis Machine Corporation 68 Buttonwood Street Bristol, RI 02809 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-09-14 |
| Summary: | summary |