FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPY INTRA-OPERATIVE IMAGING SYSTEM
K Number: K100371
·
Decision Feb 4, 2011
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
195
Applicant Total
13
Review Days
357
Basic Information
- Device Name
- SPY INTRA-OPERATIVE IMAGING SYSTEM
- K Number
- K100371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOVADAQ TECHNOLOGIES, INC.
- Date Received
- February 12, 2010
- Decision Date
- February 4, 2011
- Product Code
- IZI
- 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 |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | FDA class 2 | Radiology |
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