FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANT MODEL 1
K Number: K141038
·
Decision Nov 12, 2014
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
148
Applicant Total
1
Review Days
204
Basic Information
- Device Name
- ANT MODEL 1
- K Number
- K141038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADVANCED NUCLIDE TECHNOLOGIES, LLC
- Date Received
- April 22, 2014
- Decision Date
- November 12, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXK), ordered by most recent decision date.
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
GammaTile
FDA 510(k)
FDA Class 2
·Radiology
CivaDerm
FDA 510(k)
FDA Class 2
·Radiology