The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Rt Therapist Connect.
Device ID | K090683 |
510k Number | K090683 |
Device Name: | SYNGO RT THERAPIST CONNECT |
Classification | Accelerator, Linear, Medical |
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 | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-16 |
Decision Date | 2009-05-08 |
Summary: | summary |