6 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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COMPRESSION ANASTOMOSIS CLIP (CAC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPRESSION ANASTOMOSIS CLIP (CAC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sight OLO CBC Test Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·S.D. Sight Diagnostics Ltd·1 device
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024
Meditrac Medical Equipment Ltd.
Manufacturer
🇮🇱 Israel
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·April 27, 2022