The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo. Plaza Va20a.
Device ID | K101666 |
510k Number | K101666 |
Device Name: | SYNGO. PLAZA VA20A |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
Contact | Sabine Schroedel |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-06-14 |
Decision Date | 2010-08-10 |
Summary: | summary |