SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL— 510(k) K140897

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K140897 for SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL, Substantially Equivalent on 2014-07-18. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant
Siemens Medical Solutions USA, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mavern, PA, US
Download summary PDFView on FDA.gov ↗

Adverse 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 →

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