I-125 Seeds Code: 6702
FDA 510(k) K915156 · Medi-Physics Inc. Dba Nycomed Amersham Imaging
510(k) numberK915156
Submission
- Device name
- I-125 Seeds Code: 6702
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
Arlington Heights, IL, US - Received
- November 14, 1991
- Decision date
- January 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K940632 | I-125 Rapid StrandIWI · Traditional | 09/02/1994SE |
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| K914281 | I-125 Seeds, Code: 6711KXK · Traditional | 11/22/1991SE |
| K914268 | I-125 Seeds in Carrier, Code: 6720KXK · Traditional | 11/22/1991SE |
| K811688 | Tungsten Syringe ShieldIWR · Traditional | 07/02/1981SE |
| K811677 | Krypton CartKPY · Traditional | 07/02/1981SE |
| K811118 | Krypton Masks & TubingIYT · Traditional | 06/02/1981SE |
Questions and answers
When was I-125 Seeds Code: 6702 cleared by the FDA?
I-125 Seeds Code: 6702 (K915156) received a 510(k) decision of Substantially Equivalent on January 6, 1992, 53 days after the submission was received.
What is the product code of K915156?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.