syngo.via MI Workflows VB40A, Scenium— 510(k) K191309

Name: FDA 510(k) clearance K191309
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Substantially Equivalent

Siemens Medical Soultions USA, Inc.

FDA 510(k) clearance K191309 for syngo.via MI Workflows VB40A, Scenium, Substantially Equivalent on 2019-07-19. Applicant: Siemens Medical Soultions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Soultions USA, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-05-14
Decision date: 2019-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Siemens Medical Soultions USA, Inc.

view all

K231351 — Chondral Quant2023-07-13
K200515 — syngo.CT Cardiac Planning2020-03-25

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.