Low Dose Lung Screening Option
K-Number: K190505 · 2019-06-05
ApplicantCanon Medical Systems Corporation
Decision Date2019-06-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Low Dose Lung Screening Option is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-06-05 under approval number K190505. 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 Lung Screening Option?
Low Dose Lung Screening Option is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K190505.
When was Low Dose Lung Screening Option approved by the FDA?
Low Dose Lung Screening Option received FDA 510(k) clearance on 2019-06-05, under approval number K190505.
What company makes Low Dose Lung Screening Option?
Low Dose Lung Screening Option is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Low Dose Lung Screening Option?
The FDA product code for Low Dose Lung 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.