510(k) Report

FDA applicant

Ue Lifesciences, Inc.

Philadelphia, PA3 decisions2012–20190 recalls

FDA records 3 decisions for Ue Lifesciences, Inc. (Philadelphia, PA) from 2012 to 2019: 3 510(k) clearances. Most are in product codes NKA (System, Documentation, Breast Lesion) and LHQ (System, Telethermographic (Adjunctive Use)). Its devices cite 2 predicates, 1 of them its own earlier devices. No 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2019

2012: 12015: 12019: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Ue Lifesciences, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NKASystem, Documentation, Breast Lesion2decisions
  • LHQSystem, Telethermographic (Adjunctive Use)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142926iBreastExamUe Lifesciences, Inc. · 20151cites it

What has FDA decided for it lately?

  • K190575iBreastExamUe Lifesciences, Inc. · 2019
  • K142926iBreastExamUe Lifesciences, Inc. · 2015
  • K113259Notouch BreastscanUe Lifesciences, Inc. · 2012

All 3 as Ue Lifesciences, Inc. →