SYNGO IMAGING XS— 510(k) K082430
Substantially EquivalentSiemens AG Medical Solutions
FDA 510(k) clearance K082430 for SYNGO IMAGING XS, Substantially Equivalent on 2008-11-14. Applicant: Siemens AG Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Siemens AG Medical Solutions
- 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
- Erlangen, DE
Recent devices under product code LLZ
view allMore clearances from Siemens AG Medical Solutions
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 K082430
K-number listed on FDA's recall record- Z-0550-2016 — Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
- Z-0576-2015 — Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
- Z-2111-2014 — Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
- Z-2264-2012 — syngo Imaging XS. Radiological image processing system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082430.
Data sourced from openFDA. This site is unofficial and independent of the FDA.