The following data is part of a premarket notification filed by Siemens Medical Solutions with the FDA for Syngo Us Workplace.
Device ID | K060992 |
510k Number | K060992 |
Device Name: | SYNGO US WORKPLACE |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS 1230 SHOREBIRD WAY Mountain View, CA 94043 |
Contact | Sheila W Pickering |
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 | 2006-04-11 |
Decision Date | 2006-04-28 |
Summary: | summary |