The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantx 1824 Spotfilm Device.
| Device ID | K950317 |
| 510k Number | K950317 |
| Device Name: | ADVANTX 1824 SPOTFILM DEVICE |
| Classification | Device, Spot-film |
| Applicant | GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-26 |
| Decision Date | 1995-02-08 |