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 |