510(k) Report

FDA applicant

GE Medical Systems SCS

Buc, FR38 decisions2008–202616 recalls

FDA records 38 decisions for GE Medical Systems SCS (Buc, FR) from 2008 to 2026: 38 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 13 of them its own earlier devices. 16 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 Medical Systems SCS’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2008: 12009: 22012: 42013: 12014: 22016: 22018: 12019: 22020: 52021: 32022: 42023: 32024: 22025: 42026 (partial year): 2
2008high 5 (2020) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

5in 2026

2013: 12014: 22015: 12016: 22018: 22024: 32026 (partial year): 5
2008high 5 (2026) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — GE Medical Systems SCS by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed16decisions
  • LLZSystem, Image Processing, Radiological12decisions
  • OWBInterventional Fluoroscopic X-Ray System5decisions
  • KPSSystem, Tomography, Computed, Emission3decisions
  • MUEFull Field Digital, System, X-Ray, Mammographic2decisions

How long do its 510(k) reviews take?

Since 2016, its 28 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 10 of its 28 were faster than that.

Whose devices does it build on?

Its devices cite 51 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 13 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.

  • K092639Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EPGE Medical Systems SCS · 20097cite it
  • K073153Cardiq Function XpressGE Medical Systems SCS · 20082cite it
  • K120910Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS · 20122cite it
  • K121827Gsi Viewer with Vue OptionGE Medical Systems SCS · 20122cite it
  • K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS · 20122cite it
  • K213725CardIQ SuiteGE Medical Systems SCS · 20222cite it

What has FDA decided for it lately?

  • K253770CardIQ SuiteGE Medical Systems SCS · 2026
  • K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS · 2026
  • K251199Allia MoveoGE Medical Systems SCS · 20251 recall
  • K243672CardIQ SuiteGE Medical Systems SCS · 2025
  • K243651VersaViewerGE Medical Systems SCS · 2025
  • K2434463DXRGE Medical Systems SCS · 2025
  • K233731CardIQ SuiteGE Medical Systems SCS · 2024
  • K233714BreViewGE Medical Systems SCS · 2024

All 38 as GE Medical Systems SCS →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K251199Allia Moveo angiographic X-ray systemApr 20, 2026Class II
  • K232344Allia IGS Pulse angiographic X-ray systemApr 20, 2026Class II
  • K232344Allia IGS 5 Pulse angiographic X-ray systemApr 20, 2026Class II
  • K232344Allia IGS 3 Pulse angiographic X-ray systemApr 20, 2026Class II
  • K232344Allia IGS 7 Pulse angiographic X-ray systemApr 20, 2026Class II
  • K232344GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systemsMar 18, 2024Class II