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FDA 510(k)

BRIT PACS SYSTEMS

K-Number: K081168 · 2009-03-23

ApplicantBrit Systems, Inc.
Decision Date2009-03-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRIT PACS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Brit Systems, Inc.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K081168. 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 BRIT PACS SYSTEMS?

BRIT PACS SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Brit Systems, Inc.. The 510(k) number is K081168.

When did BRIT PACS SYSTEMS receive FDA 510(k) clearance?

BRIT PACS SYSTEMS received FDA 510(k) clearance on 2009-03-23, under 510(k) number K081168.

Who is the listed applicant for BRIT PACS SYSTEMS?

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

What is the FDA product code for BRIT PACS SYSTEMS?

The FDA product code for BRIT PACS SYSTEMS is LLZ.

Related Clinical Trials

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.

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Other records listing Brit Systems, 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.

K943383IMAGING WORKBENCH

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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