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FDA 510(k)

DEXTROSCOPE & DEXTROBEAM

K-Number: K053162 · 2005-12-09

ApplicantVolume Interactions Pte, Ltd.
Decision Date2005-12-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEXTROSCOPE & DEXTROBEAM is the device name listed in this FDA 510(k) record. The listed applicant is Volume Interactions Pte, Ltd.. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K053162. 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 DEXTROSCOPE & DEXTROBEAM?

DEXTROSCOPE & DEXTROBEAM is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Volume Interactions Pte, Ltd.. The 510(k) number is K053162.

When did DEXTROSCOPE & DEXTROBEAM receive FDA 510(k) clearance?

DEXTROSCOPE & DEXTROBEAM received FDA 510(k) clearance on 2005-12-09, under 510(k) number K053162.

Who is the listed applicant for DEXTROSCOPE & DEXTROBEAM?

The FDA 510(k) record lists Volume Interactions Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXTROSCOPE & DEXTROBEAM?

The FDA product code for DEXTROSCOPE & DEXTROBEAM is LLZ.

Related Clinical Trials

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Other records listing Volume Interactions Pte, Ltd. 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.

K071054RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4K063730DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0K032924RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3K022938VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3

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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