510(k) K231854
K231854 is an FDA 510(k) premarket notification submitted by Stryker for the device "1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM". The FDA issued a decision of Substantially Equivalent on September 20, 2023. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Stryker has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2023
- Date Received
- June 23, 2023
- Clearance Type
- Traditional
- 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.