The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia.net.
Device ID | K110844 |
510k Number | K110844 |
Device Name: | SYMBIA.NET |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192 |
Contact | Elaine Chang |
Correspondent | Elaine Chang SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-28 |
Decision Date | 2011-04-20 |
Summary: | summary |