FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K Number: K990193
·
Decision May 20, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
6
Review Days
119
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Basic Information
- Device Name
- IODINE BRACHYTHERAPY SEEDS, MODEL 3000
- K Number
- K990193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implant Sciences Corp.
- Date Received
- January 21, 1999
- Decision Date
- May 20, 1999
- 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 Implant Sciences Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 | Mar 23, 2007 | Substantially Equivalent |
| K042864 | IMPLANT SCIENCES CORP, MODEL HDR-4140 | Jan 6, 2005 | Substantially Equivalent |
| K023073 | SEED LINK | Apr 7, 2003 | Substantially Equivalent |
| K023242 | I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE | Dec 4, 2002 | Substantially Equivalent |
| K994317 | I-PLANT, MODEL 3500 | Mar 21, 2000 | Substantially Equivalent |