The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Multileaf Intensity Modulating Collimator.
| Device ID | K940412 |
| 510k Number | K940412 |
| Device Name: | MULTILEAF INTENSITY MODULATING COLLIMATOR |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | NOMOS CORP. 2593 WEXFORD BAYNE RD. SUITE 315 Sewickley, PA 15143 |
| Contact | Harris S Targovnik, Ph.d. |
| Correspondent | Harris S Targovnik, Ph.d. NOMOS CORP. 2593 WEXFORD BAYNE RD. SUITE 315 Sewickley, PA 15143 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-27 |
| Decision Date | 1995-02-15 |