510(k) Report

FDA applicant

Sentinelle Medical, Inc.

Toronto, Ontario, CA5 decisions2006–20111 recall

FDA records 5 decisions for Sentinelle Medical, Inc. (Toronto, Ontario, CA) from 2006 to 2011: 5 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LLZ (System, Image Processing, Radiological). Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sentinelle Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12009: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sentinelle Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sentinelle Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty3decisions
  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060873Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa SystemsSentinelle Medical, Inc. · 20063cite it
  • K100113Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51Sentinelle Medical, Inc. · 20103cite it
  • K070244AEGISSentinelle Medical, Inc. · 20072cite it
  • K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 20092cite it
  • K103274Sentinelle Endo Coil Array for Pelvic ImagingSentinelle Medical, Inc. · 20111cites it

What has FDA decided for it lately?

  • K103274Sentinelle Endo Coil Array for Pelvic ImagingSentinelle Medical, Inc. · 2011
  • K100113Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51Sentinelle Medical, Inc. · 20101 recall
  • K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
  • K070244AEGISSentinelle Medical, Inc. · 2007
  • K060873Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa SystemsSentinelle Medical, Inc. · 2006

All 5 as Sentinelle Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K100113Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil…May 6, 2016Class II