Kinepict Medical Imaging Tool 4.0— 510(k) K202056

Substantially Equivalent

Kinepict Health, Ltd.

FDA 510(k) clearance K202056 for Kinepict Medical Imaging Tool 4.0, Substantially Equivalent on 2021-09-10. Applicant: Kinepict Health, Ltd..

Clearance details

Applicant: Kinepict Health, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-07-24
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budakeszi, 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.