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FDA 510(k)

Kinepict Medical Imaging Tool 4.0

K-Number: K202056 · 2021-09-10

ApplicantKinepict Health, Ltd.
Decision Date2021-09-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kinepict Medical Imaging Tool 4.0 is a medical device manufactured by Kinepict Health, Ltd.. It received FDA 510(k) clearance on 2021-09-10 under approval number K202056. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kinepict Medical Imaging Tool 4.0?

Kinepict Medical Imaging Tool 4.0 is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Kinepict Health, Ltd.. The 510(k) number is K202056.

When was Kinepict Medical Imaging Tool 4.0 approved by the FDA?

Kinepict Medical Imaging Tool 4.0 received FDA 510(k) clearance on 2021-09-10, under approval number K202056.

What company makes Kinepict Medical Imaging Tool 4.0?

Kinepict Medical Imaging Tool 4.0 is manufactured by Kinepict Health, Ltd..

What is the FDA product code for Kinepict Medical Imaging Tool 4.0?

The FDA product code for Kinepict Medical Imaging Tool 4.0 is LLZ.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41839210 Artificial Intelligence in Radiology: Unlocking New Dimensions of Value. RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin (2026)

Other Devices by Kinepict Health, Ltd.

K190993Kinepict Medical Imaging Tool version v2.2

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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