The following data is part of a premarket notification filed by Medcyc. Corp. with the FDA for Medcyc Superconduct Isocen Neutron Therapy Sys.
| Device ID | K852804 |
| 510k Number | K852804 |
| Device Name: | MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS |
| Classification | System, Radiation Therapy, Neutron, Medical |
| Applicant | MEDCYC. CORP. 609 BEECH ST. East Lansing, MI 48823 |
| Contact | William R Num,my |
| Correspondent | William R Num,my MEDCYC. CORP. 609 BEECH ST. East Lansing, MI 48823 |
| Product Code | IWL |
| CFR Regulation Number | 892.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-03 |
| Decision Date | 1985-10-15 |