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FDA 510(k)

Methinks NCCT Stroke

K-Number: K250685 · 2025-06-16

ApplicantMethinks Software, S.L
Decision Date2025-06-16
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Methinks NCCT Stroke is the device name listed in this FDA 510(k) record. The listed applicant is Methinks Software, S.L. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K250685. 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 Methinks NCCT Stroke?

Methinks NCCT Stroke is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Methinks Software, S.L. The 510(k) number is K250685.

When did Methinks NCCT Stroke receive FDA 510(k) clearance?

Methinks NCCT Stroke received FDA 510(k) clearance on 2025-06-16, under 510(k) number K250685.

Who is the listed applicant for Methinks NCCT Stroke?

The FDA 510(k) record lists Methinks Software, S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Methinks NCCT Stroke?

The FDA product code for Methinks NCCT Stroke is QAS.

Other records listing Methinks Software, S.L 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.

K251590Methinks CTA Stroke

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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