The following data is part of a premarket notification filed by Mrc Systems Gmbh with the FDA for Moduleaf.
| Device ID | K030609 |
| 510k Number | K030609 |
| Device Name: | MODULEAF |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE D-69123 |
| Contact | Joerg Stein |
| Correspondent | Joerg Stein MRC SYSTEMS GMBH HANS-BUNTE-STR. 10 Heidelberg, DE D-69123 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-26 |
| Decision Date | 2003-03-17 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MODULEAF 78097851 2688756 Live/Registered |
SIEMENS MEDICAL SOLUTIONS USA, INC. 2001-12-12 |