Syngo X-workplace SW VD10— 510(k) K143319
Substantially EquivalentSiemens 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.. Device class: 2.
Clearance details
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mavern, PA, US
Recent devices under product code LLZ
view allMore clearances from Siemens Medi Cal Solutions, Inc.
view allAdverse 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 →
Recalls naming K143319
K-number listed on FDA's recall record- Z-1232-2016 — syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
- Z-0597-2016 — Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143319.
Data sourced from openFDA. This site is unofficial and independent of the FDA.