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510(k) K991571

10 CURIE IRDIUM 192, CSN00100-192 by Alpha-Omega Services, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2000
Date Received
May 5, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Alpha-Omega Services, Inc.

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  • K233626 — AOS Marker Seeds (SMG0242-025) (July 2, 2024)
  • K102811 — AOS ORION IR-192 SOURCE CABLE (June 2, 2011)
  • K062824 — AOS UNIVERSAL CONECTING GUIDE TUBE (July 3, 2007)
  • K062823 — AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES (May 29, 2007)
  • K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS (May 22, 2007)
  • K062825 — AOS MARKER SEEDS (May 22, 2007)
  • K964910 — AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS (March 10, 1997)

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  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)