AI Platform 2.2 (AIP002)— 510(k) K260217
Substantially EquivalentExo Imaging
FDA 510(k) clearance K260217 for AI Platform 2.2 (AIP002), Substantially Equivalent on 2026-02-24. Applicant: Exo Imaging. Device class: 2.
Summary
Exo Imaging's AI Platform 2.2 (AIP002) is filed under product code QIH, automated radiological image processing software. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Exo Imaging filed from Santa Clara, California. The substantially equivalent decision came 32 calendar days after receipt (January 23 to February 24, 2026).
Clearance details
- Applicant
- Exo Imaging
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Santa Clara, CA, US
Recent devices under product code QIH
view allMore clearances from Exo Imaging
view allData sourced from openFDA. This site is unofficial and independent of the FDA.