FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IsoSphere
K Number: K242818
·
Decision Jul 15, 2025
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
5
Review Days
300
Basic Information
- Device Name
- IsoSphere
- K Number
- K242818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isoaid, LLC
- Date Received
- September 18, 2024
- Decision Date
- July 15, 2025
- 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, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Dec 5, 2014 | Substantially Equivalent |
| 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 |