syngo®.via (version VB10A)— 510(k) K150843

Name: FDA 510(k) clearance K150843
Creator: U.S. Food and Drug Administration
Published: 2015-04-24

Substantially Equivalent

Siemens AG

FDA 510(k) clearance K150843 for syngo®.via (version VB10A), Substantially Equivalent on 2015-04-24. Applicant: Siemens AG. Device class: 2.

Clearance details

Applicant: Siemens AG
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-03-30
Decision date: 2015-04-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Erlangen, DE

Download summary PDF View on FDA.gov ↗

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More clearances from Siemens AG

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K123375 — SYNGO.VIA2012-11-20
K110366 — SYNGO.CT CARDIAC FUNCTION2011-04-12
K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE2007-06-08
K063507 — SYNGO NEURO PBV CT2006-11-30
K063373 — FLEX LOOP COIL SET 3T2006-11-17

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 →

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