FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-SEED
K Number: K103319
·
Decision Jan 3, 2011
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
5
Review Days
52
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Basic Information
- Device Name
- I-SEED
- K Number
- K103319
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theragenics Corp.
- Date Received
- November 12, 2010
- Decision Date
- January 3, 2011
- 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 Theragenics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Sep 26, 2007 | Substantially Equivalent |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | Jan 26, 2005 | Substantially Equivalent |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | Apr 26, 2001 | Substantially Equivalent |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Dec 22, 1987 | Substantially Equivalent |