FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XOFT AXXENT CERVICAL APPLICATORS
K Number: K123442
·
Decision Feb 27, 2013
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
14
Review Days
111
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Basic Information
- Device Name
- XOFT AXXENT CERVICAL APPLICATORS
- K Number
- K123442
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icad, Inc.
- Date Received
- November 8, 2012
- Decision Date
- February 27, 2013
- Product Code
- JAQ
- 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 |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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