FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACKLEAF-10
K Number: K071701
·
Decision Jul 23, 2007
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
22
Review Days
32
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Basic Information
- Device Name
- TRACKLEAF-10
- K Number
- K071701
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Direx Systems Corp.
- Date Received
- June 21, 2007
- Decision Date
- July 23, 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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| K061713 | MAGIS1;MAGIS2 | Jul 21, 2006 | Substantially Equivalent |
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