The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Fluorescence Imaging Vision System.
| Device ID | K124031 |
| 510k Number | K124031 |
| Device Name: | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM |
| Classification | Confocal Optical Imaging |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-12-28 |
| Decision Date | 2013-09-13 |
| Summary: | summary |