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510(k) K214093

VSP Bolus by 3D Systems — Product Code IXI

K214093 is an FDA 510(k) premarket notification submitted by 3D Systems for the device "VSP Bolus". The FDA issued a decision of Substantially Equivalent on March 30, 2022. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. 3D Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2022
Date Received
December 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type

Other clearances by 3D Systems

  • K261826 — VSP System (Titanium Palatal Splint) (June 3, 2026)
  • K250711 — VSP Orthopedics System (December 5, 2025)
  • K243174 — Cadence Ankle PSI System (October 25, 2024)
  • K243173 — Salto Talaris Ankle PSI System (October 25, 2024)
  • K241148 — Salto Talaris Ankle PSI System (August 30, 2024)
  • K241326 — Cadence Ankle PSI System (August 30, 2024)
  • K231834 — VSP PEEK Cranial Implant (April 4, 2024)
  • K231585 — Vantage PSI System (June 30, 2023)
  • K211244 — VSP® Orthopedics System (November 10, 2021)
  • K210347 — VSP System (April 26, 2021)

Other clearances for product code IXI

  • K253025 — Ricoh 3D for Healthcare Bolus (April 6, 2026)
  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • K131150 — CURA COMPENSATOR (July 30, 2013)
  • K123893 — CURA COLLIMATOR (March 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)

FDA data resources