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The machines that count blood cells for the full blood count checked before every chemotherapy cycle, and cameras with software that find and sort cells on a blood or bone marrow slide for a specialist to review.
Automated cell counters are FDA product code GKZ. Sysmex's XN-Series analysers (K141681, 5 December 2014) enumerate red and white cells, platelets and immature granulocytes in whole blood and cells in body fluids; the smaller XN-L followed (K182389, 25 January 2019), and Beckman Coulter's UniCel DxH 900 (K240252, 5 July 2024). Digital morphology systems locate and pre-classify cells on stained slides for a trained operator to confirm: CellaVision DC-1 (K200595, 16 October 2020), Scopio Labs' X100 for peripheral blood (K201301, 2 October 2020) and SigTuple's AI100 (K221309, 19 September 2023). Scopio's X100 with full field bone marrow aspirate application received De Novo classification on 22 March 2024 (DEN230034), creating product code SAL; it "assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation", with every classification reviewed by a qualified operator.
Impedance, fluorescence flow cytometry and light scatter count and classify cells in a diluted blood sample; digital morphology systems scan a stained slide, image each cell and use classifiers to propose a cell type.
Query for this technology: (TITLE:"Haematology analysers and digital blood film and marrow morphology" OR ABSTRACT:"Haematology analysers and digital blood film and marrow morphology" OR TITLE:"Sysmex XN, DxH 900, CellaVision, Scopio" OR ABSTRACT:"Sysmex XN, DxH 900, CellaVision, Scopio" OR TITLE:"Full blood count analyser" OR ABSTRACT:"Full blood count analyser" OR TITLE:"Complete blood count analyser" OR ABSTRACT:"Complete blood count analyser") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio), not a curated reading list.
Shares Acute myeloid leukaemia and the tag devices-gaps-2026-11.
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Shares Myelodysplastic syndromes / neoplasms (MDS), Chronic lymphocytic leukaemia, Acute myeloid leukaemia, Multiple myeloma.
Shares Myelodysplastic syndromes / neoplasms (MDS), Chronic lymphocytic leukaemia, Acute myeloid leukaemia, Multiple myeloma.
Shares Myelodysplastic syndromes / neoplasms (MDS), Chronic lymphocytic leukaemia, Acute myeloid leukaemia.
Shares Beckman Coulter, Flow cytometers, Myelodysplastic syndromes / neoplasms (MDS), Chronic lymphocytic leukaemia.
Shares Myelodysplastic syndromes / neoplasms (MDS), Chronic lymphocytic leukaemia, Acute myeloid leukaemia.
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