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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2018-05-16 under 510(k) 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. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K180901.

When did Low Dose CT Lung Cancer Screening Option receive FDA 510(k) clearance?

Low Dose CT Lung Cancer Screening Option received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180901.

Who is the listed applicant for Low Dose CT Lung Cancer Screening Option?

The FDA 510(k) record lists Hitachi Healthcare Americas as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Hitachi Healthcare Americas 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.

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Related Devices (Code: 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.

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