510(k) Report

FDA applicant

Ge Imatron

South San Fransisco, CA1 decision2002–20020 recalls

FDA records 1 decision for Ge Imatron (South San Fransisco, CA) in 2002: 1 510(k) clearance. All are in product code JAK (System, X-Ray, Tomography, Computed). 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 Imatron’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ge Imatron since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report