Cleared Traditional

K214093 - VSP Bolus

K214093 is an FDA 510(k) clearance for VSP Bolus, manufactured by 3D Systems. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K214093 · 3D Systems · Radiology device
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Mar 2022
Decision
92d
Days
Class 2
Risk

K214093 is an FDA 510(k) clearance for the VSP Bolus. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on March 30, 2022 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K214093

510(k) Number K214093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2021
Decision Date March 30, 2022
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 13
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K214093.
Ricoh 3D for Healthcare Bolus
K253025 · Ricoh 3D For Healthcare, LLC · Apr 2026
VHA Radiotherapy Bolus
K222639 · Vha Dean · Nov 2022
MICROMLC
K032790 · Siemens Medical Solutions USA, Inc. · Oct 2003
ENHANCED COMPENSATING FILTER
K000137 · Computerized Medical Systems, Inc. · Apr 2000
ANGIO-CT MIYABI
K990491 · Siemens Medical Solutions USA, Inc. · Apr 1999
SATURNE MULTILEAF COLLIMATOR
K970303 · General Electric Co. · Apr 1997