The following data is part of a premarket notification filed by General Electric Co. with the FDA for Intraoperative Radiation Therapy Devices.
| Device ID | K891261 |
| 510k Number | K891261 |
| Device Name: | INTRAOPERATIVE RADIATION THERAPY DEVICES |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-04-26 |