Radioactive IODINE-125 Sources
FDA 510(k) K912170 · Best Industries
510(k) numberK912170
Submission
- Device name
- Radioactive IODINE-125 Sources
- Applicant
- Best Industries
Springfield, VA, US - Received
- May 16, 1991
- Decision date
- August 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K852542 | Palladium Seed Model 100IWI · Traditional | Nuclear Medicine, Inc. | 01/14/1986SE |
More from Nuclear Medicine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940121 | Implanters/Adjustable/Anderson's MarkersIWJ · Traditional | 12/30/1994SE |
| K940119 | Royal Marsden Gold Grain GunIWS · Traditional | 12/30/1994SE |
| K933410 | Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of…IWJ · Traditional | 12/30/1994SE |
| K932242 | Radioactive Samarium 145 Seeds/Sources #2341-2345KXK · Traditional | 07/27/1993SE |
| K930570 | Radioactive Palladium 103 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K924290 | Best Industries Cartridge & GunIWJ · Traditional | 06/04/1993SE |
| K924261 | Radioactive CESIUM-131 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K910862 | Various Template ApplicatorsIWJ · Traditional | 04/18/1991SE |
Questions and answers
When was Radioactive IODINE-125 Sources cleared by the FDA?
Radioactive IODINE-125 Sources (K912170) received a 510(k) decision of Substantially Equivalent on August 9, 1991, 85 days after the submission was received.
What is the product code of K912170?
The FDA product code is IWI – Source, Isotope, Sealed, Gold, Titanium, Platinum, a Class II (moderate risk) device regulated under 21 CFR 892.5730.