The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Neuro Pbv-ir.
| Device ID | K111052 |
| 510k Number | K111052 |
| Device Name: | SYNGO NEURO PBV-IR |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MAIL CODE G01 Malvern, PA 19355 -1406 |
| Contact | Gary L Johnson |
| Correspondent | Gary L Johnson SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MAIL CODE G01 Malvern, PA 19355 -1406 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2011-05-20 |
| Summary: | summary |