Transparency Registry · applicant

Ge Medical Systems, LLC: 5 FDA AI clearances

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

Is this your company? This profile is built from public FDA records and read by hospital governance and procurement teams verifying clearances. Vendors can add public disclosure links to their entries free of charge, a verified profile adds your website, governance contact and sealed governance record to this page, and the vendor resources page covers what buyers now ask for in diligence. Corrections: hello@healthcareaiops.com.

Device	Decision date	Category
Critical Care Suite with Enteric Tube Positioning AI Algorithm	2026-04-14	QIH
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite	2023-05-25	QBS
Auto Segmentation	2023-05-04	QKB
Critical Care Suite with Endotracheal Tube Positing AI algorithm	2021-10-29	QIH
Critical Care Suite	2019-08-12	QFM

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, LLC? The disclosure rows on your entries update free on submission of public links — start here.

Link to this page. Many companies reference their registry listing from press pages and footers — it is a neutral, weekly-verified public record. Copy either snippet:

Text link:

<a href="https://healthcareaiops.com/registry/company/ge-medical-systems-llc/">Ge Medical Systems, LLC — FDA AI clearances, verified in the Healthcare AI Transparency Registry</a>

Badge:

<a href="https://healthcareaiops.com/registry/company/ge-medical-systems-llc/" 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">✓ 5 FDA AI clearances · Transparency Registry</a>

The diligence kit — free, no email needed.

The vendor due-diligence checklist (interactive, stores nothing) · the contract rider (paste-ready, CC BY) · the live clearance report (weekly, citable) · the record verifier.

One email each Monday: what changed in FDA AI clearances, in two minutes. Unsubscribe any time.

Going deeper? The Compliance & Regulatory AI Toolkit ($97) is the complete evaluation workbook, and HAI-OS keeps the governance record once a tool is deployed. Vendors: a verified profile puts your website, governance contact and sealed governance record on Ge Medical Systems, LLC’s registry page ($950/yr, human-reviewed).