FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPY FLUORESCENT IMAGING SYSTEM
K Number: K073088
·
Decision Jan 10, 2008
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
15
Review Days
70
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Basic Information
- Device Name
- SPY FLUORESCENT IMAGING SYSTEM
- K Number
- K073088
- 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
- November 1, 2007
- Decision Date
- January 10, 2008
- 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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Other Clearances by Novadaq Technologies, Inc.
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|---|---|---|---|
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| K150956 | PINPOINT Endoscopic Fluorescence Imaging System | May 23, 2016 | Substantially Equivalent |
| K123013 | ENDOSCOPIC INTRODUCER | Mar 22, 2013 | Substantially Equivalent |
| K100371 | SPY INTRA-OPERATIVE IMAGING SYSTEM | Feb 4, 2011 | Substantially Equivalent |
| K091515 | SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM | Jul 9, 2009 | Substantially Equivalent |
| K081792 | SPY ANALYSIS TOOLKIT, MODEL SA9000 | Sep 17, 2008 | Substantially Equivalent |
| K073130 | SPY FLUORESCENT IMAGING SYSTEM | Jan 10, 2008 | Substantially Equivalent |
| K071619 | SPY FLUORESCENT IMAGING SYSTEM | Nov 9, 2007 | Substantially Equivalent |
| K072222 | SPY FLUORESCENT IMAGING SYSTEM | Sep 7, 2007 | Substantially Equivalent |