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FDA 510(k)

Kinepict Medical Imaging Tool version v2.2

K-Number: K190993 · 2020-03-05

ApplicantKinepict Health, Ltd.
Decision Date2020-03-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kinepict Medical Imaging Tool version v2.2 is a medical device manufactured by Kinepict Health, Ltd.. It received FDA 510(k) clearance on 2020-03-05 under approval number K190993. 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 version v2.2?

Kinepict Medical Imaging Tool version v2.2 is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Kinepict Health, Ltd.. The 510(k) number is K190993.

When was Kinepict Medical Imaging Tool version v2.2 approved by the FDA?

Kinepict Medical Imaging Tool version v2.2 received FDA 510(k) clearance on 2020-03-05, under approval number K190993.

What company makes Kinepict Medical Imaging Tool version v2.2?

Kinepict Medical Imaging Tool version v2.2 is manufactured by Kinepict Health, Ltd..

What is the FDA product code for Kinepict Medical Imaging Tool version v2.2?

The FDA product code for Kinepict Medical Imaging Tool version v2.2 is LLZ.

Related Clinical Trials

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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.

K202056Kinepict Medical Imaging Tool 4.0

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Official Source

View on FDA Database →

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