The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Coherence Rt Therapist Connect Workspace, V2.3, Aria Connectivity Option For Siemens Non-imaging Systems, Aria Connectiv.
Device ID | K123812 |
510k Number | K123812 |
Device Name: | COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-11 |
Decision Date | 2013-03-01 |
Summary: | summary |