Low Dose CT Lung Cancer Screening Option
K-Number: K180901 · 2018-05-16
ApplicantHitachi Healthcare Americas
Decision Date2018-05-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Low Dose CT Lung Cancer Screening Option is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2018-05-16 under approval number K180901. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Low Dose CT Lung Cancer Screening Option?
Low Dose CT Lung Cancer Screening Option is a medical device that received FDA 510(k) clearance on 2018-05-16. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K180901.
When was Low Dose CT Lung Cancer Screening Option approved by the FDA?
Low Dose CT Lung Cancer Screening Option received FDA 510(k) clearance on 2018-05-16, under approval number K180901.
What company makes Low Dose CT Lung Cancer Screening Option?
Low Dose CT Lung Cancer Screening Option is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for Low Dose CT Lung Cancer Screening Option?
The FDA product code for Low Dose CT Lung Cancer Screening Option is JAK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.