The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Scenium Ve20 Software.
| Device ID | K173597 |
| 510k Number | K173597 |
| Device Name: | Scenium VE20 Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Contact | Veronica Padharia |
| Correspondent | Veronica Padharia Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869147925 | K173597 | 000 |