Lawrence Cserion, Model CS-1

FDA 510(k) K030162 · Isoray, Inc.

Substantially Equivalent

510(k) numberK030162

Submission

Device name
Lawrence Cserion, Model CS-1
Applicant
Isoray, Inc.
Richland, WA, US
Received
January 16, 2003
Decision date
March 28, 2003
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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 Lawrence Cserion, Model CS-1 cleared by the FDA?

Lawrence Cserion, Model CS-1 (K030162) received a 510(k) decision of Substantially Equivalent on March 28, 2003, 71 days after the submission was received.

What is the product code of K030162?

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