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FDA 510(k)

REX, VERSION 3.0

K-Number: K030457 · 2003-04-08

ApplicantPointdx, Inc.
Decision Date2003-04-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REX, VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Pointdx, Inc.. It received FDA 510(k) clearance on 2003-04-08 under 510(k) number K030457. 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 REX, VERSION 3.0?

REX, VERSION 3.0 is a medical device that received FDA 510(k) clearance on 2003-04-08. The listed applicant is Pointdx, Inc.. The 510(k) number is K030457.

When did REX, VERSION 3.0 receive FDA 510(k) clearance?

REX, VERSION 3.0 received FDA 510(k) clearance on 2003-04-08, under 510(k) number K030457.

Who is the listed applicant for REX, VERSION 3.0?

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

What is the FDA product code for REX, VERSION 3.0?

The FDA product code for REX, VERSION 3.0 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 Pointdx, 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.

K021099REX, VERSION 1.0

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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