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FDA 510(k)

INFINITT CARDIOLOGY PACS

K-Number: K082706 · 2008-11-06

ApplicantInfinitt Co., Ltd.
Decision Date2008-11-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINITT CARDIOLOGY PACS is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Co., Ltd.. It received FDA 510(k) clearance on 2008-11-06 under 510(k) number K082706. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITT CARDIOLOGY PACS?

INFINITT CARDIOLOGY PACS is a medical device that received FDA 510(k) clearance on 2008-11-06. The listed applicant is Infinitt Co., Ltd.. The 510(k) number is K082706.

When did INFINITT CARDIOLOGY PACS receive FDA 510(k) clearance?

INFINITT CARDIOLOGY PACS received FDA 510(k) clearance on 2008-11-06, under 510(k) number K082706.

Who is the listed applicant for INFINITT CARDIOLOGY PACS?

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

What is the FDA product code for INFINITT CARDIOLOGY PACS?

The FDA product code for INFINITT CARDIOLOGY PACS is LLZ.

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Other records listing Infinitt 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.

K163290INFINITT ULiteK111660XELIS CARDIACK111613XELIS FUSIONK103130XELIS 3DK102684XELIS DENTALK082990INFINITT XELIS

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Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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