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FDA 510(k)

INTELLISPACE PACS 4.X

K-Number: K111804 · 2011-07-28

ApplicantPhilips Healthcare Informatics, Inc.
Decision Date2011-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTELLISPACE PACS 4.X is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare Informatics, Inc.. It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K111804. 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 INTELLISPACE PACS 4.X?

INTELLISPACE PACS 4.X is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Philips Healthcare Informatics, Inc.. The 510(k) number is K111804.

When did INTELLISPACE PACS 4.X receive FDA 510(k) clearance?

INTELLISPACE PACS 4.X received FDA 510(k) clearance on 2011-07-28, under 510(k) number K111804.

Who is the listed applicant for INTELLISPACE PACS 4.X?

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

What is the FDA product code for INTELLISPACE PACS 4.X?

The FDA product code for INTELLISPACE PACS 4.X 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 Philips Healthcare Informatics, 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.

K182926IntelliSpace Radiology

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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