510(k) Report

FDA applicant

Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc

Milwaukee, WI2 decisions2003–20040 recalls

FDA records 2 decisions for Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc (Milwaukee, WI) from 2003 to 2004: 2 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 5 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, radiology panel, where it files most

How often FDA has decided Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Med. Systems Ultrasound & Prim.…’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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K032656GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 20032cite it
  • K040251GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 20041cites it

What has FDA decided for it lately?

  • K040251GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004
  • K032656GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2003

All 2 as Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc →