Syngo X-workplace SW VD10— 510(k) K143319

Substantially Equivalent

Siemens Medi Cal Solutions, Inc.

FDA 510(k) clearance K143319 for Syngo X-workplace SW VD10, Substantially Equivalent on 2015-02-24. Applicant: Siemens Medi Cal Solutions, Inc..

Clearance details

Applicant
Siemens Medi Cal Solutions, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mavern, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.