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FDA 510(k)

INTELEPACS

K-Number: K032533 · 2003-10-16

ApplicantIntelerad Medical Systems, Inc.
Decision Date2003-10-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTELEPACS is the device name listed in this FDA 510(k) record. The listed applicant is Intelerad Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-10-16 under 510(k) number K032533. 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 INTELEPACS?

INTELEPACS is a medical device that received FDA 510(k) clearance on 2003-10-16. The listed applicant is Intelerad Medical Systems, Inc.. The 510(k) number is K032533.

When did INTELEPACS receive FDA 510(k) clearance?

INTELEPACS received FDA 510(k) clearance on 2003-10-16, under 510(k) number K032533.

Who is the listed applicant for INTELEPACS?

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

What is the FDA product code for INTELEPACS?

The FDA product code for INTELEPACS 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 Intelerad Medical 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.

K070080INTELEPACS

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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