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Mammogram machines fitted with a needle guide, which take X-rays from two angles or a 3D scan to work out exactly where a tiny abnormality is, so a biopsy needle can be aimed at something that cannot be felt or seen on ultrasound.
These attachments and tables are cleared as mammographic X-ray systems (FDA product code IZH, 21 CFR 892.1710). Examples include Hologic's Affirm prone biopsy system (K153486, 1 April 2016) and Affirm Contrast Biopsy (K202294, 5 October 2020), which targets lesions seen on contrast-enhanced mammography, Fujifilm's biopsy positioner (K191495, 3 July 2019) and IMS Giotto's SMART FINDER (K203509, 14 July 2021). They are used mostly for calcifications found on screening mammograms. The needle itself is usually a vacuum-assisted probe.
Paired stereo images or a tomosynthesis volume give the three-dimensional coordinates of a target in the compressed breast; a motorised guide places the needle at those coordinates.
Query for this technology: (TITLE:"Stereotactic and tomosynthesis-guided breast biopsy systems" OR ABSTRACT:"Stereotactic and tomosynthesis-guided breast biopsy systems" OR TITLE:"Affirm, Giotto, Fujifilm positioner" OR ABSTRACT:"Affirm, Giotto, Fujifilm positioner" OR TITLE:"Stereotactic breast biopsy" OR ABSTRACT:"Stereotactic breast biopsy" OR TITLE:"Tomosynthesis-guided biopsy" OR ABSTRACT:"Tomosynthesis-guided biopsy") 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 Stereotactic and tomosynthesis-guided breast biopsy systems (Affirm, Giotto, Fujifilm positioner), not a curated reading list.
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Shares Core needle biopsy and fine-needle aspiration (FNA) and the tag devices-gaps-2026-11.
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Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
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