MOD1T Compensators for Radiation Beam Therapy

FDA 510(k) K091403 · Oncology Tech, LLC

Substantially Equivalent

510(k) numberK091403

Submission

Device name
MOD1T Compensators for Radiation Beam Therapy
Applicant
Oncology Tech, LLC
San Antonio, TX, US
Received
May 12, 2009
Decision date
July 29, 2009
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 MOD1T Compensators for Radiation Beam Therapy cleared by the FDA?

MOD1T Compensators for Radiation Beam Therapy (K091403) received a 510(k) decision of Substantially Equivalent on July 29, 2009, 78 days after the submission was received.

What is the product code of K091403?

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