The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Innova 2100-iq, Innova 3100, Innova 3100-iq, Innova 4100, And Innova 4100-iq.
| Device ID | K052412 |
| 510k Number | K052412 |
| Device Name: | INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2005-09-16 |
| Summary: | summary |