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FDA 510(k)

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

K-Number: K220935 · 2022-12-29

ApplicantIren-Medical, Ltd.
Decision Date2022-12-29
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is a medical device manufactured by Iren-Medical, Ltd.. It received FDA 510(k) clearance on 2022-12-29 under approval number K220935. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Iren-Medical, Ltd.. The 510(k) number is K220935.

When was Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App approved by the FDA?

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App received FDA 510(k) clearance on 2022-12-29, under approval number K220935.

What company makes Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is manufactured by Iren-Medical, Ltd..

What is the FDA product code for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

The FDA product code for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is FKX.

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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: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026)

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Official Source

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

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