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FDA 510(k)

qCT LN Quant

K-Number: K240740 · 2024-08-16

Decision Date2024-08-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qCT LN Quant is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K240740. 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 qCT LN Quant?

qCT LN Quant is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Qure.Ai Technologies. The 510(k) number is K240740.

When did qCT LN Quant receive FDA 510(k) clearance?

qCT LN Quant received FDA 510(k) clearance on 2024-08-16, under 510(k) number K240740.

Who is the listed applicant for qCT LN Quant?

The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qCT LN Quant?

The FDA product code for qCT LN Quant is QIH.

Other records listing Qure.Ai Technologies 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.

View all 9 devices →

Related Devices (Code: QIH)

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.

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.