I-125 Rapid Strand

FDA 510(k) K940632 · Medi-Physics Inc. Dba Nycomed Amersham Imaging

Substantially Equivalent

510(k) numberK940632

Submission

Device name
I-125 Rapid Strand
Applicant
Medi-Physics Inc. Dba Nycomed Amersham Imaging
Arlington Heights, IL, US
Received
February 14, 1994
Decision date
September 2, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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)DeviceApplicantDecision
K973363North American SCIENTIFIC(NASI)PD-103 Radionuclide Brachytherapy Source-Model MED3633IWI · Traditional Ml Strategies, Inc.07/02/1998SE
K912170Radioactive IODINE-125 SourcesIWI · Traditional Best Industries08/09/1991SE
K882449Cesium 137 Source, Model CSM-40IWI · Traditional Cis-Us, Inc.04/14/1989SE
K874787Modified Palladium Seed Model 100IWI · Traditional Theragenics Corp.12/22/1987SE
K852542Palladium Seed Model 100IWI · Traditional Nuclear Medicine, Inc.01/14/1986SE

More from Nuclear Medicine, Inc.

510(k)DeviceDecision
K010821ECHOSEED/IODINE-125 Seeds, Model 6733KXK · Special 04/11/2001SE
K921961Sdmo Applicator Code: ASN.8236IWJ · Traditional 07/01/1992SE
K915156I-125 Seeds Code: 6702KXK · Traditional 01/06/1992SE
K914281I-125 Seeds, Code: 6711KXK · Traditional 11/22/1991SE
K914268I-125 Seeds in Carrier, Code: 6720KXK · Traditional 11/22/1991SE
K811688Tungsten Syringe ShieldIWR · Traditional 07/02/1981SE
K811677Krypton CartKPY · Traditional 07/02/1981SE
K811118Krypton Masks & TubingIYT · Traditional 06/02/1981SE

Questions and answers

When was I-125 Rapid Strand cleared by the FDA?

I-125 Rapid Strand (K940632) received a 510(k) decision of Substantially Equivalent on September 2, 1994, 200 days after the submission was received.

What is the product code of K940632?

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