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FDA 510(k)

PACS SCAN

K-Number: K083618 · 2009-01-28

ApplicantPacsgear, Inc.
Decision Date2009-01-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PACS SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Pacsgear, Inc.. It received FDA 510(k) clearance on 2009-01-28 under 510(k) number K083618. 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 PACS SCAN?

PACS SCAN is a medical device that received FDA 510(k) clearance on 2009-01-28. The listed applicant is Pacsgear, Inc.. The 510(k) number is K083618.

When did PACS SCAN receive FDA 510(k) clearance?

PACS SCAN received FDA 510(k) clearance on 2009-01-28, under 510(k) number K083618.

Who is the listed applicant for PACS SCAN?

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

What is the FDA product code for PACS SCAN?

The FDA product code for PACS SCAN 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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