InterView XP; InterView FUSION— 510(k) K221984

Substantially Equivalent

Mediso Medical Imaging Systems, Lttd.

FDA 510(k) clearance K221984 for InterView XP; InterView FUSION, Substantially Equivalent on 2023-03-29. Applicant: Mediso Medical Imaging Systems, Lttd..

Clearance details

Applicant: Mediso Medical Imaging Systems, Lttd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-07-06
Decision date: 2023-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budapest, HU

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.