The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Nomos Motorized Crane Ii.
| Device ID | K013036 |
| 510k Number | K013036 |
| Device Name: | NOMOS MOTORIZED CRANE II |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Contact | Francis X Dobscha |
| Correspondent | Francis X Dobscha NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2001-12-07 |
| Summary: | summary |