The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Precision 500d R&f X-ray System.
| Device ID | K081091 |
| 510k Number | K081091 |
| Device Name: | PRECISION 500D R&F X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GE HEALTHCARE 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Contact | Michael Petrowski |
| Correspondent | Michael Petrowski GE HEALTHCARE 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-06-11 |
| Summary: | summary |