Transparency Registry · applicant

Ortho Ai, LLC: 1 FDA AI clearance

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

Device	Decision date	Category
Ortho AI	2025-01-02	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 Ortho Ai, 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/ortho-ai-llc/">Ortho Ai, LLC — FDA AI clearances, verified in the Healthcare AI Transparency Registry</a>

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<a href="https://healthcareaiops.com/registry/company/ortho-ai-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">✓ 1 FDA AI clearance · Transparency Registry</a>