The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Tomo-link.
| Device ID | K944967 |
| 510k Number | K944967 |
| Device Name: | TOMO-LINK |
| Classification | System, X-ray, Tomographic |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1994-12-09 |