FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AVANZA
K Number: K060870
·
Decision May 15, 2006
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
7
Review Days
46
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Basic Information
- Device Name
- AVANZA
- K Number
- K060870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mds Nordion
- Date Received
- March 30, 2006
- Decision Date
- May 15, 2006
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
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| K011246 | DCM 1.0 | May 23, 2001 | Substantially Equivalent |
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