The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Iplan Rt.
Device ID | K103246 |
510k Number | K103246 |
Device Name: | IPLAN RT |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Contact | Alexander Schwiersch |
Correspondent | Alexander Schwiersch BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-03 |
Decision Date | 2011-03-16 |
Summary: | summary |