Isostar I-125 Interstitial Seed, Model IS-12501
FDA 510(k) K991526 · Imagyn Medical Technologies, Inc.
510(k) numberK991526
Submission
- Device name
- Isostar I-125 Interstitial Seed, Model IS-12501
- Applicant
- Imagyn Medical Technologies, Inc.
Costa Mesa, CA, US - Received
- May 3, 1999
- Decision date
- June 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Isostar I-125 Interstitial Seed, Model IS-12501 cleared by the FDA?
Isostar I-125 Interstitial Seed, Model IS-12501 (K991526) received a 510(k) decision of Substantially Equivalent on June 17, 1999, 45 days after the submission was received.
What is the product code of K991526?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.