SIENET COSMOS— 510(k) K033831

Name: FDA 510(k) clearance K033831
Creator: U.S. Food and Drug Administration
Published: 2003-12-19

Substantially Equivalent

Siemens AG Medical Solutions

FDA 510(k) clearance K033831 for SIENET COSMOS, Substantially Equivalent on 2003-12-19. 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: 2003-12-10
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eriangen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K033831

K-number listed on FDA's recall record

Z-1622-2014 — syngo Imaging XS 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 postprocessing applications.Class II·Terminated·Siemens Medical Solutions USA, Inc·20140403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033831.

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

Clearance details

Recent devices under product code LLZ

More clearances from Siemens AG Medical Solutions

Adverse events under product code LLZ

Recalls naming K033831