Modified Palladium Seed Model 100

FDA 510(k) K874787 · Theragenics Corp.

Substantially Equivalent

510(k) numberK874787

Submission

Device name
Modified Palladium Seed Model 100
Applicant
Theragenics Corp.
Atlanta, GA, US
Received
November 23, 1987
Decision date
December 22, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IWI – Source, Isotope, Sealed, Gold, Titanium, Platinum
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology

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K940632I-125 Rapid StrandIWI · Traditional Medi-Physics Inc. Dba Nycomed Amersham Imaging09/02/1994SE
K912170Radioactive IODINE-125 SourcesIWI · Traditional Best Industries08/09/1991SE
K882449Cesium 137 Source, Model CSM-40IWI · Traditional Cis-Us, Inc.04/14/1989SE
K852542Palladium Seed Model 100IWI · Traditional Nuclear Medicine, Inc.01/14/1986SE

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Questions and answers

When was Modified Palladium Seed Model 100 cleared by the FDA?

Modified Palladium Seed Model 100 (K874787) received a 510(k) decision of Substantially Equivalent on December 22, 1987, 29 days after the submission was received.

What is the product code of K874787?

The FDA product code is IWI – Source, Isotope, Sealed, Gold, Titanium, Platinum, a Class II (moderate risk) device regulated under 21 CFR 892.5730.