Cura Collimator

FDA 510(k) K123893 · Cura Medical Technologies, LLC

Substantially Equivalent

510(k) numberK123893

Submission

Device name
Cura Collimator
Applicant
Cura Medical Technologies, LLC
Lake Forest, CA, US
Received
December 18, 2012
Decision date
March 4, 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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Questions and answers

When was Cura Collimator cleared by the FDA?

Cura Collimator (K123893) received a 510(k) decision of Substantially Equivalent on March 4, 2013, 76 days after the submission was received.

What is the product code of K123893?

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