Spy Imaging System
510(k) K063345
Spy Imaging System is a medical device (FDA Class II; FDA product code IZI, System, X-Ray, Angiographic) made by Novadaq Technologies Inc, cleared under FDA 510(k) K063345 on 12 Jan 2007, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063345 | Date12 Jan 2007 | StatusActive |
Official records
- FDA 510(k) database K063345
Recalls
-
- Terminated Z-2767-2016
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.
Timeline
- Cleared FDA 510(k) K063345
- Recall initiated FDA recalls Z-2767-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZI
- FDA applicant
- Novadaq Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1600
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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