{"entity":{"id":"stereotactic-breast-biopsy","kind":"technology","name":"Stereotactic and tomosynthesis-guided breast biopsy systems (Affirm, Giotto, Fujifilm positioner)","aka":["Stereotactic breast biopsy","Tomosynthesis-guided biopsy","Prone biopsy table","Affirm","Affirm Contrast Biopsy","Giotto SMART FINDER"],"tldr":"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.","summary":"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.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA product code IZH: mammographic X-ray system","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=IZH"},{"label":"FDA 510(k) K153486: Affirm prone biopsy system (1 April 2016)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153486"},{"label":"FDA 510(k) K202294: Affirm Contrast Biopsy (5 October 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202294"},{"label":"FDA 510(k) K191495: Fujifilm biopsy positioner (3 July 2019)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191495"},{"label":"FDA 510(k) K203509: IMS Giotto SMART FINDER (14 July 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203509"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["breast-cancer"],"sections":["diagnostics","imaging","devices"],"technologies":["vacuum-assisted-breast-biopsy","mammography","contrast-enhanced-mammography","breast-lesion-localisation"],"targets":[],"drugs":[],"companies":["hologic","fujifilm"],"institutions":[],"pathways":[],"terms":["core-needle-biopsy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"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.","strengths":["Targets calcifications invisible on ultrasound","Contrast-guided versions reach lesions seen only after contrast"],"limitations":["Breast compression for the length of the procedure","Lesions very close to the chest wall can be hard to reach"],"since":2016},"route":"/technologies/stereotactic-breast-biopsy/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"}],"technology":[{"id":"breast-lesion-localisation","kind":"technology","name":"Breast lesion localisation markers (wire, magnetic seed, radar reflector, RFID tag)","route":"/technologies/breast-lesion-localisation/"},{"id":"contrast-enhanced-mammography","kind":"technology","name":"Contrast-enhanced mammography","route":"/technologies/contrast-enhanced-mammography/"},{"id":"mammography","kind":"technology","name":"Mammography & tomosynthesis","route":"/technologies/mammography/"},{"id":"vacuum-assisted-breast-biopsy","kind":"technology","name":"Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera)","route":"/technologies/vacuum-assisted-breast-biopsy/"}],"company":[{"id":"fujifilm","kind":"company","name":"FUJIFILM Healthcare","route":"/companies/fujifilm/"},{"id":"hologic","kind":"company","name":"Hologic","route":"/companies/hologic/"}],"term":[{"id":"core-needle-biopsy","kind":"term","name":"Core needle biopsy and fine-needle aspiration (FNA)","route":"/terms/core-needle-biopsy/"}]}}