The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Advantage Windows Ct/pet Fusion.
| Device ID | K010336 |
| 510k Number | K010336 |
| Device Name: | ADVANTAGE WINDOWS CT/PET FUSION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-02-05 |
| Decision Date | 2001-02-16 |