FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIOMED MARKER
K Number: K022326
·
Decision Jan 31, 2003
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
5
Review Days
197
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Basic Information
- Device Name
- RADIOMED MARKER
- K Number
- K022326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiomed Corporation
- Date Received
- July 18, 2002
- Decision Date
- January 31, 2003
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 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 |
| K070305 | PRE-LOADED VISICOIL | Mar 7, 2007 | Substantially Equivalent |
| K013660 | GENETRA | Dec 5, 2001 | Substantially Equivalent |