AI Platform 2.2 (AIP002)— 510(k) K260217

Substantially Equivalent

Exo Imaging

FDA 510(k) clearance K260217 for AI Platform 2.2 (AIP002), Substantially Equivalent on 2026-02-24. Applicant: Exo Imaging. Device class: 2.

Clearance details

Applicant: Exo Imaging
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-23
Decision date: 2026-02-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, CA, 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

More clearances from Exo Imaging

K240953 — AI Platform 2.0 (AIP002)2024-08-05

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