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FDA 510(k)

HealthFLD

K-Number: K233080 · 2024-02-08

ApplicantNano-X AI , Ltd.
Decision Date2024-02-08
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HealthFLD is the device name listed in this FDA 510(k) record. The listed applicant is Nano-X AI , Ltd.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K233080. 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 HealthFLD?

HealthFLD is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Nano-X AI , Ltd.. The 510(k) number is K233080.

When did HealthFLD receive FDA 510(k) clearance?

HealthFLD received FDA 510(k) clearance on 2024-02-08, under 510(k) number K233080.

Who is the listed applicant for HealthFLD?

The FDA 510(k) record lists Nano-X AI , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthFLD?

The FDA product code for HealthFLD is JAK.

Other records listing Nano-X AI , Ltd. 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.

K241440HealthCCSng

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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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