Transparency Registry · applicant

GE Medical Systems Ultrasound and Primary Care Diagnostics: 2 FDA AI clearances

Every 510(k) clearance held by GE Medical Systems Ultrasound and Primary Care Diagnostics under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.

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Device	Decision date	Category
EchoPAC Software Only / EchoPAC Plug-in	2025-07-16	QIH
EchoPAC Software Only, EchoPAC Plug-in	2022-07-22	QIH

Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for GE Medical Systems Ultrasound and Primary Care Diagnostics? The disclosure rows on your entries update free on submission of public links — start here.

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<a href="https://healthcareaiops.com/registry/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics/">GE Medical Systems Ultrasound and Primary Care Diagnostics — FDA AI clearances, verified in the Healthcare AI Transparency Registry</a>

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<a href="https://healthcareaiops.com/registry/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics/" style="display:inline-block;border:1px solid #E3E5E8;border-left:3px solid #0F62FE;padding:6px 12px;font:600 12px sans-serif;color:#16191D;text-decoration:none">✓ 2 FDA AI clearances · Transparency Registry</a>

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