Cura Compensator

FDA 510(k) K131150 · Cura Medical Technologies, LLC

Substantially Equivalent

510(k) numberK131150

Submission

Device name
Cura Compensator
Applicant
Cura Medical Technologies, LLC
Lake Forest, CA, US
Received
April 23, 2013
Decision date
July 30, 2013
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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More from .Decimal, Inc.

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Questions and answers

When was Cura Compensator cleared by the FDA?

Cura Compensator (K131150) received a 510(k) decision of Substantially Equivalent on July 30, 2013, 98 days after the submission was received.

What is the product code of K131150?

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