FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
K Number: K062384
·
Decision Nov 9, 2006
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
3
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
- K Number
- K062384
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isoray, Inc.
- Date Received
- August 15, 2006
- Decision Date
- November 9, 2006
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXK), ordered by most recent decision date.
OncoPatch
FDA 510(k)
FDA Class 2
·Radiology
IsoSphere
FDA 510(k)
FDA Class 2
·Radiology
RadianceTx Radionuclide Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology
GammaTile
FDA 510(k)
FDA Class 2
·Radiology
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
FDA 510(k)
FDA Class 2
·Radiology
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
FDA 510(k)
FDA Class 2
·Radiology