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FDA 510(k)

VSP Bolus

K-Number: K214093 · 2022-03-30

Applicant3D Systems
Decision Date2022-03-30
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VSP Bolus is a medical device manufactured by 3D Systems. It received FDA 510(k) clearance on 2022-03-30 under approval number K214093. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSP Bolus?

VSP Bolus is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by 3D Systems. The 510(k) number is K214093.

When was VSP Bolus approved by the FDA?

VSP Bolus received FDA 510(k) clearance on 2022-03-30, under approval number K214093.

What company makes VSP Bolus?

VSP Bolus is manufactured by 3D Systems.

What is the FDA product code for VSP Bolus?

The FDA product code for VSP Bolus is IXI.

Other Devices by 3D Systems

K193432Vantage PSI System K192192VSP System K211244VSP® Orthopedics System K210347VSP System

Related Devices (Code: IXI)

K222639VHA Radiotherapy BolusVha Dean K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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