CESIUM-137 Microseed Source Train Assembly/Shield

Q: What is the product code of K894409?

The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.

FDA 510(k) K894409 · Amersham Corp.

Substantially Equivalent

510(k) numberK894409

Submission

Device name: CESIUM-137 Microseed Source Train Assembly/Shield
Applicant: Amersham Corp.
Arlington Heights, IL, US
Received: July 17, 1989
Decision date: September 29, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: IWA – Source, Wire, Iridium, Radioactive
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5730
Specialty: Radiology

Other 510(k)s with product code IWA

510(k)	Device	Applicant	Decision
K915253	IR-192 Implant, ModificationIWA · Traditional	Omnitron Intl., Inc.	02/27/1992SE
K874895	IR-192 ImplantIWA · Traditional	Rads S.L., Inc.	02/25/1988SE
K850382	Iridium SeedsIWA · Traditional	Radiation Safety & Nuclear Products, Inc.	08/15/1985SE
K844248	IR-192 ImplantIWA · Traditional	Rads S.L., Inc.	04/10/1985SE
K850726	Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional	Syncor Intl. Corp.	03/26/1985SE
K850163	Iridium 192 WiresIWA · Traditional	Syncor Intl. Corp.	03/26/1985SE
K771878	Iridium 192 Wires & PinsIWA · Traditional	Cis Radiopharmaceuticals, Inc.	10/27/1977SE

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K901848	GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional	07/09/1990SE
K901832	GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional	07/09/1990SE
K896270	Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional	12/12/1989SE

Questions and answers

When was CESIUM-137 Microseed Source Train Assembly/Shield cleared by the FDA?

CESIUM-137 Microseed Source Train Assembly/Shield (K894409) received a 510(k) decision of Substantially Equivalent on September 29, 1989, 74 days after the submission was received.

What is the product code of K894409?

The FDA product code is IWA – Source, Wire, Iridium, Radioactive, a Class II (moderate risk) device regulated under 21 CFR 892.5730.