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FDA 510(k)

INTELEPACS, MODEL VERSION 3.X.X

K-Number: K083520 · 2009-06-23

ApplicantIntelerad Medical Systems Incorporated
Decision Date2009-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTELEPACS, MODEL VERSION 3.X.X is the device name listed in this FDA 510(k) record. The listed applicant is Intelerad Medical Systems Incorporated. It received FDA 510(k) clearance on 2009-06-23 under 510(k) number K083520. 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, MODEL VERSION 3.X.X?

INTELEPACS, MODEL VERSION 3.X.X is a medical device that received FDA 510(k) clearance on 2009-06-23. The listed applicant is Intelerad Medical Systems Incorporated. The 510(k) number is K083520.

When did INTELEPACS, MODEL VERSION 3.X.X receive FDA 510(k) clearance?

INTELEPACS, MODEL VERSION 3.X.X received FDA 510(k) clearance on 2009-06-23, under 510(k) number K083520.

Who is the listed applicant for INTELEPACS, MODEL VERSION 3.X.X?

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

What is the FDA product code for INTELEPACS, MODEL VERSION 3.X.X?

The FDA product code for INTELEPACS, MODEL VERSION 3.X.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 Intelerad Medical Systems Incorporated 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.

K192176IntelePACS

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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