Cleared Special

K053162 - DEXTROSCOPE & DEXTROBEAM

K053162 is an FDA 510(k) clearance for DEXTROSCOPE & DEXTROBEAM, manufactured by Volume Interactions Pte, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K053162 · Volume Interactions Pte, Ltd. · Radiology device
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Dec 2005
Decision
25d
Days
Class 2
Risk

K053162 is an FDA 510(k) clearance for the DEXTROSCOPE & DEXTROBEAM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Volume Interactions Pte, Ltd. (Tower, Singapore, SG). The FDA issued a Cleared decision on December 9, 2005 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

FDA 510(k) Submission Details - K053162

510(k) Number K053162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date December 09, 2005
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K053162.
BRAIN VIEWRX VIEWER, VERSION 1.0
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K052120 · Heeyoung Co., Ltd. · Dec 2005
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K052632 · Vital Images, Inc. · Dec 2005
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
K053281 · Emageon, Inc. · Dec 2005
MEDIQ VERSION 1.0
K052963 · Clario Medical Imaging, Inc. · Dec 2005
SYNGO DYNAMICS, VERSION 5.0
K053133 · Siemens Medical Solutions USA, Inc. · Dec 2005
K053162 · DEXTROSCOPE & DEXTROBEAM
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