The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Rt Interface.
Device ID | K120363 |
510k Number | K120363 |
Device Name: | SYNGO RT INTERFACE |
Classification | System, Planning, Radiation Therapy Treatment |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
Contact | Christine Dunbar |
Correspondent | Christine Dunbar SIEMENS MEDICAL SOLUTIONS USA, INC. 4040 NELSON AVE. Concord, CA 94520 |
Product Code | MUJ |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-06 |
Decision Date | 2012-03-20 |
Summary: | summary |