FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OARTRAC SYSTEM
K Number: K141154
·
Decision Jul 22, 2014
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
3
Review Days
78
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Basic Information
- Device Name
- OARTRAC SYSTEM
- K Number
- K141154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiadyne
- Date Received
- May 5, 2014
- Decision Date
- July 22, 2014
- Product Code
- NZT
- 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 |
|---|---|---|---|
| NZT | Dosimeter, Ionizing Radiation, Implanted | FDA class 2 | Radiology |
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