RadCalc Software— 510(k) K193381

Substantially Equivalent

Lifeline Software, Inc.

FDA 510(k) clearance K193381 for RadCalc Software, Substantially Equivalent on 2019-12-31. Applicant: Lifeline Software, Inc.. Device class: 2.

Clearance details

Applicant: Lifeline Software, Inc.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2019-12-05
Decision date: 2019-12-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lifeline Software, Inc.

K090531 — RADCALC SOFTWARE, VERSION 6.02009-05-27
K010464 — RADCALC, MODEL V.4.02001-05-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.