FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OARtrac System with Patient Specific Reusable Universal PSD Sensors
K Number: K162954
·
Decision Jun 1, 2017
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
2
Review Days
220
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Basic Information
- Device Name
- OARtrac System with Patient Specific Reusable Universal PSD Sensors
- K Number
- K162954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiadyne, LLC
- Date Received
- October 24, 2016
- Decision Date
- June 1, 2017
- 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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Other Clearances by Radiadyne, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K150719 | OARtrac System with Skin Sensors | Jun 16, 2015 | Substantially Equivalent |