# Breast lesion localisation markers (wire, magnetic seed, radar reflector, RFID tag)

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

## TL;DR

When a breast cancer is too small to feel, a radiologist places a marker in it before surgery so the surgeon can find it. The marker used to be a fine wire; now it is often a tiny seed or tag that a probe detects during the operation.

## Summary

Non-wire markers are cleared as implantable radiographic markers (FDA product code NEU) or temporary tissue markers (PBY). Endomag's Magseed magnetic marker (K173587, 16 February 2018) is indicated "to radiographically mark soft tissue during a surgical procedure or for future surgical procedures". Cianna Medical's SAVI Scout reflector and system (K181007, 2 August 2018) uses radar; its successor SCOUT MD is now with Merit Medical (K231468, 12 February 2024; K252892, 19 December 2025). Health Beacons' RFID localization system (K181692, K190932, K193189) places a tag "in the breast to mark (>30 days) a lesion intended for surgical removal". Sirius Pintuition (K200734, 24 February 2021, and later K222643 and K223682) uses a titanium seed for "temporary (<30 days) marking of a lumpectomy site", and MOLLI (K210600, 16 April 2021; MOLLI 2 under Stryker, K253888, 31 December 2025) is a magnetic marker "implanted for less than 30 days". Elucent's EnVisio navigation system was cleared on 22 March 2019 (K183400). Mammotome, which acquired Endomag, sells Magseed with the Sentimag probe. The NCI dictionary describes the older method, wire localisation, in which a wire placed under imaging leads the surgeon to the area.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-11-04
- Also known as: Wire localisation; Wire-guided localisation; Seed localisation; Magseed; SAVI SCOUT; SCOUT MD; LOCalizer; RFID localisation; Pintuition; MOLLI; EnVisio
- Tags: devices-gaps-2026-11
- Principle: A marker placed under ultrasound or mammographic guidance is detected in theatre by a handheld probe that reads its magnetic, radar, radiofrequency identification or electromagnetic signal, guiding excision without a wire leaving the skin.
- Since: 2018
- Strengths: Marker can be placed days or weeks before surgery, separating radiology and theatre schedules; No wire protruding from the breast
- Limitations: Placing the marker is an extra procedure before surgery; Each system needs its own detector in theatre

## Sources

- FDA 510(k) K173587: Endomag Magseed (16 February 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173587
- FDA 510(k) K181007: SAVI Scout reflector and system (2 August 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181007
- FDA 510(k) K231468: SCOUT MD (12 February 2024): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231468
- FDA 510(k) K252892: SCOUT MD (19 December 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252892
- FDA 510(k) K193189: Health Beacons RFID localization system (6 May 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K193189
- FDA 510(k) K200734: Sirius Pintuition (24 February 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200734
- FDA 510(k) K223682: Sirius Pintuition (9 November 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223682
- FDA 510(k) K210600: MOLLI (16 April 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210600
- FDA 510(k) K253888: MOLLI 2 System, Stryker (31 December 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253888
- FDA 510(k) K183400: EnVisio navigation system (22 March 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183400
- NCI Dictionary: wire localization: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/wire-localization

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Imaging](https://onco.cc/fronts/imaging/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [Magnetic tracer for sentinel lymph node biopsy (Magtrace and Sentimag)](https://onco.cc/technologies/magnetic-sentinel-node-tracer/), [Sentinel lymph node biopsy](https://onco.cc/technologies/sentinel-node/), [Stereotactic and tomosynthesis-guided breast biopsy systems (Affirm, Giotto, Fujifilm positioner)](https://onco.cc/technologies/stereotactic-breast-biopsy/), [Vacuum-assisted breast biopsy systems (Mammotome, EnCor, Eviva, Brevera)](https://onco.cc/technologies/vacuum-assisted-breast-biopsy/)
- companies: [Mammotome (Danaher)](https://onco.cc/companies/mammotome/), [Stryker](https://onco.cc/companies/stryker/)

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