The following data is part of a premarket notification filed by Mrc Systems Gmbh with the FDA for Mini Multileaf Collimator, Model Kmi.
| Device ID | K011816 |
| 510k Number | K011816 |
| Device Name: | MINI MULTILEAF COLLIMATOR, MODEL KMI |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE 69123 |
| Contact | Jorg Stein |
| Correspondent | Jorg Stein MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE 69123 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2001-09-07 |
| Summary: | summary |