FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-LOADED VISICOIL
K Number: K070305
·
Decision Mar 7, 2007
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
5
Review Days
34
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Basic Information
- Device Name
- PRE-LOADED VISICOIL
- K Number
- K070305
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiomed Corporation
- Date Received
- February 1, 2007
- Decision Date
- March 7, 2007
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 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 |
| K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | Apr 19, 2012 | Substantially Equivalent |
| K022326 | RADIOMED MARKER | Jan 31, 2003 | Substantially Equivalent |
| K013660 | GENETRA | Dec 5, 2001 | Substantially Equivalent |