The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Real Time Stereotix.
| Device ID | K941191 |
| 510k Number | K941191 |
| Device Name: | REAL TIME STEREOTIX |
| Classification | System, X-ray, Mammographic |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1995-05-11 |