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FDA 510(k)

BriefCase-Quantification

K-Number: K230534 · 2023-11-08

ApplicantAidoc Medical , Ltd.
Decision Date2023-11-08
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BriefCase-Quantification is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K230534. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BriefCase-Quantification?

BriefCase-Quantification is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K230534.

When did BriefCase-Quantification receive FDA 510(k) clearance?

BriefCase-Quantification received FDA 510(k) clearance on 2023-11-08, under 510(k) number K230534.

Who is the listed applicant for BriefCase-Quantification?

The FDA 510(k) record lists Aidoc Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BriefCase-Quantification?

The FDA product code for BriefCase-Quantification is QIH.

Other records listing Aidoc Medical , Ltd. as applicant

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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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