FDA-Device2019-04-24Class II
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Siemens Healthcare Diagnostics, Inc.
Hazard
Software Issues.
Sold states
Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Affected count
449 systems
Manufactured in
500 Gbc Dr Ms 514, N/A, Newark, DE, United States
Products
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1195-2019Don't want to check this manually?
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