The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Symbia.net, Symbia.net Select Model 10520828, 10520827.
| Device ID | K100619 |
| 510k Number | K100619 |
| Device Name: | SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 2501 NORTH BARRINGTON ROAD Hoffman Estates, IL 60192 |
| Contact | Elaine Chang |
| Correspondent | Elaine Chang SIEMENS MEDICAL SOLUTIONS USA INC. 2501 NORTH BARRINGTON ROAD 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 | 2010-03-04 |
| Decision Date | 2010-05-07 |
| Summary: | summary |