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FDA 510(k)

IPACS PRISM-5.0

K-Number: K050298 · 2005-02-28

ApplicantRealtimeimage, Inc.
Decision Date2005-02-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IPACS PRISM-5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Realtimeimage, Inc.. It received FDA 510(k) clearance on 2005-02-28 under 510(k) number K050298. 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 PRISM-5.0?

IPACS PRISM-5.0 is a medical device that received FDA 510(k) clearance on 2005-02-28. The listed applicant is Realtimeimage, Inc.. The 510(k) number is K050298.

When did IPACS PRISM-5.0 receive FDA 510(k) clearance?

IPACS PRISM-5.0 received FDA 510(k) clearance on 2005-02-28, under 510(k) number K050298.

Who is the listed applicant for IPACS PRISM-5.0?

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 PRISM-5.0?

The FDA product code for IPACS PRISM-5.0 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.

K042781IPACS CARDIOK041366IPACS ORTHOK030751IPACS 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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