The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantage Windows 3d Option And Dentascan Option.
| Device ID | K923077 |
| 510k Number | K923077 |
| Device Name: | ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1993-02-02 |