510(k) K203550
K203550 is an FDA 510(k) premarket notification submitted by Activ Surgical, Inc. for the device "ActivSight Intraoperative Imaging System". The FDA issued a decision of Substantially Equivalent on April 8, 2021. The device falls under product code OWN (Confocal Optical Imaging), a Class II device regulated under 21 CFR 876.1500. Activ Surgical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2021
- Date Received
- December 4, 2020
- 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.