The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Vert-x.
| Device ID | K061873 |
| 510k Number | K061873 |
| Device Name: | VERT-X |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Contact | Larisa Gershtein |
| Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-08-18 |
| Summary: | summary |