FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPY ANALYSIS TOOLKIT, MODEL SA9000
K Number: K081792
·
Decision Sep 17, 2008
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
13
Review Days
84
Basic Information
- Device Name
- SPY ANALYSIS TOOLKIT, MODEL SA9000
- K Number
- K081792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOVADAQ TECHNOLOGIES, INC.
- Date Received
- June 25, 2008
- Decision Date
- September 17, 2008
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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