Ortho AI— 510(k) K241696

Substantially Equivalent

Ortho Ai, LLC

FDA 510(k) clearance K241696 for Ortho AI, Substantially Equivalent on 2025-01-02. Applicant: Ortho Ai, LLC. Device class: 2.

Clearance details

Applicant: Ortho Ai, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-06-12
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.