The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Expedio 500d R&f X-ray System.
| Device ID | K011624 |
| 510k Number | K011624 |
| Device Name: | EXPEDIO 500D R&F X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-06-08 |
| Summary: | summary |