# Stereotactic and tomosynthesis-guided breast biopsy systems (Affirm, Giotto, Fujifilm positioner)

Source: https://onco.cc/technologies/stereotactic-breast-biopsy/  
OnCo record `stereotactic-breast-biopsy` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-11-04
- Also known as: Stereotactic breast biopsy; Tomosynthesis-guided biopsy; Prone biopsy table; Affirm; Affirm Contrast Biopsy; Giotto SMART FINDER
- Tags: devices-gaps-2026-11
- 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.
- Since: 2016
- 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

## Sources

- FDA product code IZH: mammographic X-ray system: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=IZH
- FDA 510(k) K153486: Affirm prone biopsy system (1 April 2016): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153486
- FDA 510(k) K202294: Affirm Contrast Biopsy (5 October 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202294
- FDA 510(k) K191495: Fujifilm biopsy positioner (3 July 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191495
- FDA 510(k) K203509: IMS Giotto SMART FINDER (14 July 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203509

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Imaging](https://onco.cc/fronts/imaging/)
- technologies: [Breast lesion localisation markers (wire, magnetic seed, radar reflector, RFID tag)](https://onco.cc/technologies/breast-lesion-localisation/), [Contrast-enhanced mammography](https://onco.cc/technologies/contrast-enhanced-mammography/), [Mammography & tomosynthesis](https://onco.cc/technologies/mammography/), [Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera)](https://onco.cc/technologies/vacuum-assisted-breast-biopsy/)
- companies: [FUJIFILM Healthcare](https://onco.cc/companies/fujifilm/), [Hologic](https://onco.cc/companies/hologic/)
- terms: [Core needle biopsy and fine-needle aspiration (FNA)](https://onco.cc/terms/core-needle-biopsy/)

---
JSON: https://onco.cc/api/v1/entities/stereotactic-breast-biopsy.json