FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPY Elite Intraoperative Perfusion Assessment System
K Number: K182907
·
Decision Jan 23, 2019
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
198
Applicant Total
6
Review Days
98
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Basic Information
- Device Name
- SPY Elite Intraoperative Perfusion Assessment System
- K Number
- K182907
- 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 Ulc. (Now A Part of Stryker)
- Date Received
- October 17, 2018
- Decision Date
- January 23, 2019
- Product Code
- IZI
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 Ulc. (Now A Part of Stryker)
| K Number | Device Name | ||
|---|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Nov 5, 2020 | Substantially Equivalent |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | May 21, 2020 | Substantially Equivalent |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Nov 15, 2019 | Substantially Equivalent |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | Apr 19, 2019 | Unknown |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Nov 21, 2018 | Substantially Equivalent |