510(k) K982421

Device: IMAGYN 125 I SEED, MODEL IS 125
Applicant: INTERNATIONAL ISOTOPES, INC.
510(k) number: K982421
Product code: IWG
Decision: Substantially Equivalent (SESE)
Decision date: 1998-07-31
Date received: 1998-07-13
Regulation: 892.5730
Classification name: Seed, Isotope, Gold, Titanium, Platinum
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BETSY C KING
Address: 3100 Jim Christal Rd. Denton TX US 76207 76207

FDA Registration Numbers#

1054811

Source Documents#

Other 510(k) Records For Product Code IWG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K081066	BRACHYTHERAPY SOURCE DEVICE, MODEL 9011	Medi-Physics, Inc., Dba GE Healthcare	2008-05-05
K834027	GOLD SEADS	Radiation Safety & Nuclear Products, Inc.	1983-12-27

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases