The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Mbf.
| Device ID | K110494 |
| 510k Number | K110494 |
| Device Name: | SYNGO MBF |
| 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 | 2011-02-22 |
| Decision Date | 2011-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869013770 | K110494 | 000 |
| 04056869002088 | K110494 | 000 |
| 04056869002071 | K110494 | 000 |