The following data is part of a premarket notification filed by General Electric Co. with the FDA for Saturne Multileaf Collimator.
| Device ID | K970303 |
| 510k Number | K970303 |
| Device Name: | SATURNE MULTILEAF COLLIMATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-27 |
| Decision Date | 1997-04-25 |
| Summary: | summary |