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FDA 510(k)

AVIEW Aorta Metrics

K-Number: K260391 · 2026-10-16

ApplicantCoreline Soft Co., Ltd.
Decision Date2026-10-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVIEW Aorta Metrics is the device name listed in this FDA 510(k) record. The listed applicant is Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K260391. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVIEW Aorta Metrics?

AVIEW Aorta Metrics is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K260391.

When did AVIEW Aorta Metrics receive FDA 510(k) clearance?

AVIEW Aorta Metrics received FDA 510(k) clearance on 2026-10-16, under 510(k) number K260391.

Who is the listed applicant for AVIEW Aorta Metrics?

The FDA 510(k) record lists Coreline Soft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVIEW Aorta Metrics?

The FDA product code for AVIEW Aorta Metrics is JAK.

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Other records listing Coreline Soft Co., Ltd. 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.

K251203AVIEW Lung Nodule CADK243689AVIEWK243696AVIEW CACK233211AVIEW CACK221592AVIEW Lung Nodule CADK214036AVIEW

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Related Devices (Code: JAK)

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.

K261225CAS-One IRCascination AGK261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCS

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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