The following data is part of a premarket notification filed by General Medical Merate S.p.a. with the FDA for Precision Rxi Analog X-ray System.
| Device ID | K041605 |
| 510k Number | K041605 |
| Device Name: | PRECISION RXI ANALOG X-RAY SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GENERAL MEDICAL MERATE S.P.A. 25 VIA PARTIGIANI Seriate (bg), IT 24068 |
| Contact | Kevin Walls |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-06-30 |