Rapid Strand RX

FDA 510(k) K122764 · Medi-Physics, Inc.

Substantially Equivalent

510(k) numberK122764

Submission

Device name
Rapid Strand RX
Applicant
Medi-Physics, Inc.
Arlington Heights, IL, US
Received
September 10, 2012
Decision date
December 28, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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Questions and answers

When was Rapid Strand RX cleared by the FDA?

Rapid Strand RX (K122764) received a 510(k) decision of Substantially Equivalent on December 28, 2012, 109 days after the submission was received.

What is the product code of K122764?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.