510(k) Report

FDA applicant

Ge Healthcare (Tianjin) Company Limited

Tianjin, CN6 decisions2019–202413 recalls

FDA records 6 decisions for Ge Healthcare (Tianjin) Company Limited (Tianjin, CN) from 2019 to 2024: 6 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 74 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. 13 recalls are 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 Ge Healthcare (Tianjin) Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12020: 12022: 22023: 12024: 1
2019high 2 (2022) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

3in 2025

2021: 62022: 12024: 32025: 3
2019high 6 (2021) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare (Tianjin) Company Limited by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 74 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited · 20201cites it
  • K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 20221cites it
  • K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited · 20191cites it
  • K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited · 20231cites it

What has FDA decided for it lately?

  • K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited · 2024
  • K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited · 20231 recall
  • K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited · 20221 recall
  • K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited · 20222 recalls
  • K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited · 20205 recalls
  • K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited · 20194 recalls

All 6 as Ge Healthcare (Tianjin) Company Limited →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K160618GE Signa Artist, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K213603GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K161567GE Signa Voyager, Nuclear Magnetic Resonance Imaging SystemJun 20, 2025Class II
  • K223439SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance…Jun 14, 2024Class II
  • K211980SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging…Jun 14, 2024Class II
  • K160618SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0…Jun 14, 2024Class II