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FDA 510(k)

JLK-NCCT

K-Number: K252421 · 2026-03-24

ApplicantJLK, Inc.
Decision Date2026-03-24
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JLK-NCCT is the device name listed in this FDA 510(k) record. The listed applicant is JLK, Inc.. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K252421. 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 JLK-NCCT?

JLK-NCCT is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is JLK, Inc.. The 510(k) number is K252421.

When did JLK-NCCT receive FDA 510(k) clearance?

JLK-NCCT received FDA 510(k) clearance on 2026-03-24, under 510(k) number K252421.

Who is the listed applicant for JLK-NCCT?

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

What is the FDA product code for JLK-NCCT?

The FDA product code for JLK-NCCT is QAS.

Other records listing JLK, Inc. 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.

K243611JLK-SDHK250348JLK-AILinkK243363JLK-ICHK242709JLK-PWIK242556JLK-CTPK241480JBS-LVO

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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.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , 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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