Digital Image, Storage And Communications, Non-diagnostic, Laboratory Information System
Clinical Chemistry · 21 CFR 862.2100
Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.
Recent MDR events
5 adverse event reports on file
- MODEL I 128Sep 12, 2014MalfunctionAnn Arbor Digital DevicesMW5038200
- SUNQUEST POWERPATHAug 29, 2014MalfunctionSunquest Info Systems2029302-2014-00004
- SUNQUEST POWERPATHMar 6, 2014MalfunctionSunquest Info Systems2029302-2014-00002
- SUNQUEST COPATHPLUSMar 6, 2014MalfunctionSunquest Information System2029302-2014-00001
- HORIZONMay 15, 2013MalfunctionMckesson Technologies, Inc3250736
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Equitar Technologies, Inc.
La Jolla, CA, US
Medical San Industria De Equipamentos Medicos Ltda
Estrela Rio Grande do Sul, BR
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Vistapath Biosystems Inc.
Cambridge, MA, US
Cirdan Imaging Limited
Lisburn Antrim and Newtownabbey, GB
Wellgen Medical Co., Ltd
Kaohsiung City, TW
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Clinisys, Inc
TUCSON, AZ, US
Hangzhou Diagens Biotechnology Co., Ltd.
Hangzhou Zhejiang, CN
Aspyra, Llc.
JACKSONVILLE, FL, US
Milestone S.p.a.
Sorisole Bergamo, IT
Cellsolutions Llc
Greensboro, NC, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Inami & Co., Ltd.
Bunkyo Tokyo, JP
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.