IMAGE ONE— 510(k) K250716

Substantially Equivalent

Infomed Software, S.L.

FDA 510(k) clearance K250716 for IMAGE ONE, Substantially Equivalent on 2025-07-23. Applicant: Infomed Software, S.L..

Clearance details

Applicant: Infomed Software, S.L.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-03-10
Decision date: 2025-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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