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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 the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2025-09-08 under 510(k) 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. The listed applicant is Qure.Ai Technologies. The 510(k) number is K251610.

When did qER-CTA (v1.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for qER-CTA (v1.0)?

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 qER-CTA (v1.0)?

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

Other records listing Qure.Ai Technologies as applicant

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Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

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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