The following data is part of a premarket notification filed by General Medical Merate S.p.a. with the FDA for Precision Rxi Analog And Digital X-ray Systems.
| Device ID | K082243 |
| 510k Number | K082243 |
| Device Name: | PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GENERAL MEDICAL MERATE S.P.A. 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls GENERAL MEDICAL MERATE S.P.A. 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-11-07 |