Kinepict Medical Imaging Tool version v2.2— 510(k) K190993
Substantially EquivalentKinepict Health, Ltd.
FDA 510(k) clearance K190993 for Kinepict Medical Imaging Tool version v2.2, Substantially Equivalent on 2020-03-05. Applicant: Kinepict Health, Ltd..
Clearance details
- Applicant
- Kinepict Health, Ltd.
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Budakeszi, HU
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . 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.