SPY Elite Intraoperative Perfusion Assessment System
FDA 510(k) K182907 · Novadaq Technologies Ulc. (Now A Part of Stryker)
510(k) numberK182907
Submission
- Device name
- SPY Elite Intraoperative Perfusion Assessment System
- Applicant
- Novadaq Technologies Ulc. (Now A Part of Stryker)
Burnaby, CA - Received
- October 17, 2018
- Decision date
- January 23, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN · Traditional | 11/05/2020SE |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 05/21/2020SE |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Traditional | 11/15/2019SE |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) SystemOWN · Special | 04/19/2019SESD |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Traditional | 11/21/2018SE |
Questions and answers
When was SPY Elite Intraoperative Perfusion Assessment System cleared by the FDA?
SPY Elite Intraoperative Perfusion Assessment System (K182907) received a 510(k) decision of Substantially Equivalent on January 23, 2019, 98 days after the submission was received.
What is the product code of K182907?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.