FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-LOADED GOLD VISICOIL CK MARKER
K Number: K120859
·
Decision Apr 19, 2012
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- PRE-LOADED GOLD VISICOIL CK MARKER
- K Number
- K120859
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiomed Corporation
- Date Received
- March 22, 2012
- Decision Date
- April 19, 2012
- 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 Radiomed Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) | Apr 28, 2017 | Substantially Equivalent |
| K070305 | PRE-LOADED VISICOIL | Mar 7, 2007 | Substantially Equivalent |
| K022326 | RADIOMED MARKER | Jan 31, 2003 | Substantially Equivalent |
| K013660 | GENETRA | Dec 5, 2001 | Substantially Equivalent |