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FDA 510(k)

qER-CTA (v1.0)

K-Number: K251610 · 2025-09-08

ApplicantQure.Ai Technologies
Decision Date2025-09-08
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qER-CTA (v1.0) is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2025-09-08 under approval number K251610. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the qER-CTA (v1.0)?

qER-CTA (v1.0) is a medical device that received FDA 510(k) clearance on 2025-09-08. It is manufactured by Qure.Ai Technologies. The 510(k) number is K251610.

When was qER-CTA (v1.0) approved by the FDA?

qER-CTA (v1.0) received FDA 510(k) clearance on 2025-09-08, under approval number K251610.

What company makes qER-CTA (v1.0)?

qER-CTA (v1.0) is manufactured by Qure.Ai Technologies.

What is the FDA product code for qER-CTA (v1.0)?

The FDA product code for qER-CTA (v1.0) is QAS.

Other Devices by Qure.Ai Technologies

K200921qER K212690qXR-BT K211222qER-Quant K231805qXR-LN K231149qXR-CTR K230899qXR-PTX-PE

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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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