FDA 510(k)

VSP Bolus

K-Number: K214093 · 2022-03-30

Decision Date2022-03-30

Product CodeIXI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VSP Bolus is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems. It received FDA 510(k) clearance on 2022-03-30 under 510(k) 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. The listed applicant is 3D Systems. The 510(k) number is K214093.

When did VSP Bolus receive FDA 510(k) clearance?

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

Who is the listed applicant for VSP Bolus?

The FDA 510(k) record lists 3D Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSP Bolus?

The FDA product code for VSP Bolus is IXI.

Other records listing 3D Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IXI)

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

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.