The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121.
| Device ID | K060259 |
| 510k Number | K060259 |
| Device Name: | DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W-400 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W-400 Waukesha, WI 53188 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-02-22 |
| Summary: | summary |