Device Atlas

Palladium Seed Model 100

Q: What is the product code of K852542?

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

FDA 510(k) K852542 · Nuclear Medicine, Inc.

Substantially Equivalent

510(k) numberK852542

Submission

Device name: Palladium Seed Model 100
Applicant: Nuclear Medicine, Inc.
Atlanta, GA, US
Received: June 14, 1985
Decision date: January 14, 1986
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

Other 510(k)s with product code IWI

510(k)	Device	Applicant	Decision
K973363	North American SCIENTIFIC(NASI)PD-103 Radionuclide Brachytherapy Source-Model MED3633IWI · Traditional	Ml Strategies, Inc.	07/02/1998SE
K940632	I-125 Rapid StrandIWI · Traditional	Medi-Physics Inc. Dba Nycomed Amersham Imaging	09/02/1994SE
K912170	Radioactive IODINE-125 SourcesIWI · Traditional	Best Industries	08/09/1991SE
K882449	Cesium 137 Source, Model CSM-40IWI · Traditional	Cis-Us, Inc.	04/14/1989SE
K874787	Modified Palladium Seed Model 100IWI · Traditional	Theragenics Corp.	12/22/1987SE

Questions and answers

When was Palladium Seed Model 100 cleared by the FDA?

Palladium Seed Model 100 (K852542) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 214 days after the submission was received.

What is the product code of K852542?

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