510(k) Report

FDA applicant

Ge Medical Systems Navigation and Visualization IN

Salt Lake City, UT1 decision2004–20046 recalls

FDA records 1 decision for Ge Medical Systems Navigation and Visualization IN (Salt Lake City, UT) in 2004: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 6 recalls are linked to its devices, 1 Class I.

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 Navigation and Visualization IN’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ge Medical Systems Navigation and Visualization IN since 2007.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Navigation and Visualization IN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 20043cite it

What has FDA decided for it lately?

  • K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 20041 Class I recall

The one decision as Ge Medical Systems Navigation and Visualization IN →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K040050Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare…Feb 24, 2011
  • K040050Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE…Feb 24, 2011
  • K040050InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System…Sep 15, 2006Class I
  • K040050InstaTrak 3500 Plus Navigation and Visualization SystemDec 13, 2004
  • K040050Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the…Sep 15, 2004
  • K040050InstaTrak 3500 Plus Navigation and Visualization SystemJul 12, 2004