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FDA 510(k)

RADCALC, MODEL V.4.0

K-Number: K010464 · 2001-05-17

ApplicantLifeline Software, Inc.
Decision Date2001-05-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADCALC, MODEL V.4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Lifeline Software, Inc.. It received FDA 510(k) clearance on 2001-05-17 under 510(k) number K010464. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADCALC, MODEL V.4.0?

RADCALC, MODEL V.4.0 is a medical device that received FDA 510(k) clearance on 2001-05-17. The listed applicant is Lifeline Software, Inc.. The 510(k) number is K010464.

When did RADCALC, MODEL V.4.0 receive FDA 510(k) clearance?

RADCALC, MODEL V.4.0 received FDA 510(k) clearance on 2001-05-17, under 510(k) number K010464.

Who is the listed applicant for RADCALC, MODEL V.4.0?

The FDA 510(k) record lists Lifeline Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADCALC, MODEL V.4.0?

The FDA product code for RADCALC, MODEL V.4.0 is IYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Lifeline Software, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193381RadCalc SoftwareK090531RADCALC SOFTWARE, VERSION 6.0

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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