Intersource 125, Model 1251L

FDA 510(k) K984235 · International Brachytherapy, Inc.

Substantially Equivalent

510(k) numberK984235

Submission

Device name
Intersource 125, Model 1251L
Applicant
International Brachytherapy, Inc.
Norcross, GA, US
Received
November 25, 1998
Decision date
June 9, 1999
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 Intersource 125, Model 1251L cleared by the FDA?

Intersource 125, Model 1251L (K984235) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 196 days after the submission was received.

What is the product code of K984235?

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