The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Foursight Viewtool Image Viewer.
| Device ID | K052895 |
| 510k Number | K052895 |
| Device Name: | FOURSIGHT VIEWTOOL IMAGE VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View, CA 94039 -7393 |
| Contact | Patrick J Lynch |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2005-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869003498 | K052895 | 000 |