The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Digital Fluoroscopic Imaging System, Model Innova 4100 With Tilt Table Option.
| Device ID | K033244 |
| 510k Number | K033244 |
| Device Name: | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. MAIL STOP W-400 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Donald James Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2003-10-16 |
| Summary: | summary |