FDA.reportPublic FDA data

VSP Bolus

Primary DI
00816847022613
Brand
VSP Bolus
Company
3D SYSTEMS, INC.
Model
1.0
Catalog number
VSPRT
Device description
The 3D Systems VSP Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment. VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons, electrons, or at orthovoltage X-rays.
Published
2023-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IXIBlock, Beam-Shaping, Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXIBlock, Beam-Shaping, Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214093000VSP Bolus3D Systems2022-03-30IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847022613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847022613008168470226138168470226130816847022613

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy bolus, single-useA pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G003BL0103D BolusRicoh Usa, Inc.IXI2026-05-27
00850038561048VHA Radiotherapy BolusVHA Office of Advanced Manufacturing - Ft. LawtonIXI2025-12-02
00851147007137decimal Bolus (FlexiBol)DECIMAL, INC.IXI2022-12-01
B365112680Universal Leveling Template, Set of FiveAktina Corp.IXI2021-05-21
B365112690Universal Leveling Plate System, Elekta CompatibleAktina Corp.IXI2021-05-21
B365530460Hot Wire CutterAktina Corp.IXI2021-05-21
B36511268010Universal Leveling Template, 25X25Aktina Corp.IXI2016-09-27
B36511268020Universal Leveling Template, 20X20Aktina Corp.IXI2016-09-27
B36511268030Universal Leveling Template, 14X14Aktina Corp.IXI2016-09-27
B36511268040Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-27
B36511268050Universal Leveling Template, 6X6Aktina Corp.IXI2016-09-24
B36511269010Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-24
B36511269020Universal Leveling Template, 6X10Aktina Corp.IXI2016-09-24
B365112700Electron Beam Shaping System, Elekta Compatible, Full SystemAktina Corp.IXI2016-09-24
B365112850Low Energy Beam Block SetAktina Corp.IXI2016-09-24
B365112900High Energy Beam Block SetAktina Corp.IXI2016-09-24
B365524850Electron Beam Shaping Full System, Siemens 95 cm, Full SystemAktina Corp.IXI2016-09-24
B365526260E-Beam Shaping SystemAktina Corp.IXI2016-09-24
B365534180Beam Block Set, Low EnergyAktina Corp.IXI2016-09-24
B365534260Beam Block Set, High EnergyAktina Corp.IXI2016-09-24
05060191071215Apex™ELEKTA LIMITEDIXI2016-09-24
00851147007014.decimal Proton Range CompensatorDECIMAL, INC.IXI2016-09-24
00851147007021.decimal Electron BolusDECIMAL, INC.IXI2016-09-24
00851147007038.decimal Electron ApertureDECIMAL, INC.IXI2016-09-24
00851147007045.decimal Photon BlockDECIMAL, INC.IXI2016-09-24
00851147007052.decimal Photon CompensatorDECIMAL, INC.IXI2016-09-24
00851147007007.decimal Proton ApertureDECIMAL, INC.IXI2016-09-23