ANDI 2.2— 510(k) K261405
Substantially EquivalentImeka Solutions, Inc.
FDA 510(k) clearance K261405 for ANDI 2.2, Substantially Equivalent on 2026-05-28. Applicant: Imeka Solutions, Inc.. Device class: 2.
Summary
Imeka Solutions filed ANDI 2.2 under QIH, automated radiological image processing software. The record doesn't expand "ANDI".
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Imeka filed from Sherbrooke, Canada. The decision came 29 calendar days after receipt (April 29 to May 28, 2026).
Clearance details
- Applicant
- Imeka Solutions, Inc.
- 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
- Sherbrooke, CA
Recent devices under product code QIH
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