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FDA 510(k)

RadCalc Software

K-Number: K193381 · 2019-12-31

ApplicantLifeline Software, Inc.
Decision Date2019-12-31
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadCalc Software is a medical device manufactured by Lifeline Software, Inc.. It received FDA 510(k) clearance on 2019-12-31 under approval number K193381. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadCalc Software?

RadCalc Software is a medical device that received FDA 510(k) clearance on 2019-12-31. It is manufactured by Lifeline Software, Inc.. The 510(k) number is K193381.

When was RadCalc Software approved by the FDA?

RadCalc Software received FDA 510(k) clearance on 2019-12-31, under approval number K193381.

What company makes RadCalc Software?

RadCalc Software is manufactured by Lifeline Software, Inc..

What is the FDA product code for RadCalc Software?

The FDA product code for RadCalc Software is MUJ.

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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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