The following data is part of a premarket notification filed by Siemens Ag Healthcare with the FDA for Syngo.plaza Vb10a.
| Device ID | K132532 |
| 510k Number | K132532 |
| Device Name: | SYNGO.PLAZA VB10A |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS AG HEALTHCARE HENKESTRASSE 127 Erlangen, DE 91052 |
| Contact | Viktoria Benz |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005942 | K132532 | 000 |
| 04056869005935 | K132532 | 000 |
| 04056869005782 | K132532 | 000 |
| 04056869005751 | K132532 | 000 |
| 04056869004365 | K132532 | 000 |
| 04056869001081 | K132532 | 000 |