VHA Radiotherapy Bolus

FDA 510(k) K222639 · Vha Dean

Substantially Equivalent

510(k) numberK222639

Submission

Device name
VHA Radiotherapy Bolus
Applicant
Vha Dean
Washington, DC, US
Received
September 1, 2022
Decision date
November 4, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IXI – Block, Beam-Shaping, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5710
Specialty
Radiology

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Questions and answers

When was VHA Radiotherapy Bolus cleared by the FDA?

VHA Radiotherapy Bolus (K222639) received a 510(k) decision of Substantially Equivalent on November 4, 2022, 64 days after the submission was received.

What is the product code of K222639?

The FDA product code is IXI – Block, Beam-Shaping, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5710.