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FDA 510(k)

EXAM-PACS

K-Number: K042647 · 2004-10-07

ApplicantCoactiv, LLC
Decision Date2004-10-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXAM-PACS is the device name listed in this FDA 510(k) record. The listed applicant is Coactiv, LLC. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042647. 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 EXAM-PACS?

EXAM-PACS is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Coactiv, LLC. The 510(k) number is K042647.

When did EXAM-PACS receive FDA 510(k) clearance?

EXAM-PACS received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042647.

Who is the listed applicant for EXAM-PACS?

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

What is the FDA product code for EXAM-PACS?

The FDA product code for EXAM-PACS is LLZ.

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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