Da Vinci Fluorescence Imaging Vision System
FDA 510(k) K124031 · Intuitive Surgical, Inc.
510(k) numberK124031
Submission
- Device name
- Da Vinci Fluorescence Imaging Vision System
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- December 28, 2012
- Decision date
- September 13, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
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| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
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| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
Questions and answers
When was Da Vinci Fluorescence Imaging Vision System cleared by the FDA?
Da Vinci Fluorescence Imaging Vision System (K124031) received a 510(k) decision of Substantially Equivalent on September 13, 2013, 259 days after the submission was received.
What is the product code of K124031?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.