The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Innova 2121iq, Innova 3131iq, Innova 4100, Innova 4100iq, Innova 3100, Innova 3100iq, Innova 2100iq With Innova Ivus Opt.
| Device ID | K061163 |
| 510k Number | K061163 |
| Device Name: | INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | OWB |
| Subsequent Product Code | IYO |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-06-07 |
| Summary: | summary |