FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K Number: K141701
·
Decision Dec 5, 2014
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
148
Applicant Total
4
Review Days
164
Basic Information
- Device Name
- I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
- K Number
- K141701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ISOAID, L.L.C.
- Date Received
- June 24, 2014
- Decision Date
- December 5, 2014
- 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 ISOAID, L.L.C.
| K Number | Device Name | ||
|---|---|---|---|
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | Aug 10, 2012 | Substantially Equivalent |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA | Sep 15, 2009 | Substantially Equivalent |
| K033770 | ISOAID ADVANTAGE PD-103, MODEL IAPD-103A | Apr 8, 2004 | Substantially Equivalent |