510(k) K190729
K190729 is an FDA 510(k) premarket notification submitted by Novadaq Technologies Ulc. (Now A Part Of Stryker) for the device "SPY Portable Handheld Imaging (SPY-PHI) System". The FDA issued a decision of Substantially Equivalent (with conditions) on Apr 19, 2019. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Novadaq Technologies Ulc. (Now A Part Of Stryker) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- Apr 19, 2019
- Date Received
- Mar 21, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Confocal Optical Imaging
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
Collection of light signals for visualization of cellular microstructures.