Identity
- Trade Name
- VSP Bolus FDA UDI
- Generic Name
- Radiation therapy bolus, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- VSPRT FDA UDI
- Primary DI / UDI-DI
- 00816847022613 FDA UDI
- 510(k) Number
- K214093 FDA UDI
- FDA Product Code
- IXI FDA UDI
- GMDN Term
- Radiation therapy bolus, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy bolus, single-use
VSP Bolus by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3d Systems, Inc.
Sources (1)
- FDA UDI eff78ea5-c5ed-4701-84fb-2e9ea282a2d2 35 fields · synced May 30, 2026