FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AOS MARKER SEEDS
K Number: K062825
·
Decision May 22, 2007
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
9
Review Days
244
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Basic Information
- Device Name
- AOS MARKER SEEDS
- K Number
- K062825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alpha-Omega Services, Inc.
- Date Received
- September 20, 2006
- Decision Date
- May 22, 2007
- Product Code
- KXK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Alpha-Omega Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Jul 10, 2024 | Substantially Equivalent |
| K233626 | AOS Marker Seeds (SMG0242-025) | Jul 2, 2024 | Substantially Equivalent |
| K102811 | AOS ORION IR-192 SOURCE CABLE | Jun 2, 2011 | Substantially Equivalent |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | Jul 3, 2007 | Substantially Equivalent |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | May 29, 2007 | Substantially Equivalent |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | May 22, 2007 | Substantially Equivalent |
| K991571 | 10 CURIE IRDIUM 192, CSN00100-192 | Feb 22, 2000 | Substantially Equivalent |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | Mar 10, 1997 | Substantially Equivalent |