FDA 510(k)

Spectrum IQ Infusion System, Dose IQ Safety Software

K-Number: K173084 · 2018-05-11

Decision Date2018-05-11

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Spectrum IQ Infusion System, Dose IQ Safety Software is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2018-05-11 under approval number K173084. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectrum IQ Infusion System, Dose IQ Safety Software?

Spectrum IQ Infusion System, Dose IQ Safety Software is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K173084.

When was Spectrum IQ Infusion System, Dose IQ Safety Software approved by the FDA?

Spectrum IQ Infusion System, Dose IQ Safety Software received FDA 510(k) clearance on 2018-05-11, under approval number K173084.

What company makes Spectrum IQ Infusion System, Dose IQ Safety Software?

Spectrum IQ Infusion System, Dose IQ Safety Software is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Spectrum IQ Infusion System, Dose IQ Safety Software?

The FDA product code for Spectrum IQ Infusion System, Dose IQ Safety Software is FRN.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42127793 Ethical Responsibility in the Off-Label Use of AI in Medical Imaging. The Journal of clinical ethics (2026) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 40480339 [Regulatory requirements for software medical devices: Comparison between Europe, the United States, and Algeria]. Annales pharmaceutiques francaises (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.