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FDA 510(k)

IPACS ORTHO

K-Number: K041366 · 2004-06-08

ApplicantRealtimeimage, Inc.
Decision Date2004-06-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IPACS ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Realtimeimage, Inc.. It received FDA 510(k) clearance on 2004-06-08 under 510(k) number K041366. 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 IPACS ORTHO?

IPACS ORTHO is a medical device that received FDA 510(k) clearance on 2004-06-08. The listed applicant is Realtimeimage, Inc.. The 510(k) number is K041366.

When did IPACS ORTHO receive FDA 510(k) clearance?

IPACS ORTHO received FDA 510(k) clearance on 2004-06-08, under 510(k) number K041366.

Who is the listed applicant for IPACS ORTHO?

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

What is the FDA product code for IPACS ORTHO?

The FDA product code for IPACS ORTHO 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 Realtimeimage, 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.

K050298IPACS PRISM-5.0K042781IPACS CARDIOK030751IPACS PRISM

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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