The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Advantage 4d Option.
| Device ID | K032915 |
| 510k Number | K032915 |
| Device Name: | ADVANTAGE 4D OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. W-400 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Juergen Welte TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-10-30 |
| Summary: | summary |