Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes
FDA 510(k) K120208 · Mauna Kea Technologies
510(k) numberK120208
Submission
- Device name
- Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes
- Applicant
- Mauna Kea Technologies
Orinda, CA, US - Received
- January 24, 2012
- Decision date
- April 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K220477 | Cellvizio 100 series system with confocal MiniprobesOWN · Traditional | 04/11/2022SE |
| K212322 | Cellvizio I.V.E. system with Confocal MiniprobesOWN · Special | 08/18/2021SE |
| K193416 | Cellvizio I.V.E. with Confocal MiniprobesOWN · Traditional | 02/28/2020SE |
| K191144 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 01/24/2020SE |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesOWN · Special | 02/22/2019SE |
| K180270 | Cellvizio 100 Series Systems with Confocal MiniprobesGWG · Traditional | 05/22/2018SE |
| K172844 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/15/2017SE |
| K171345 | Cellvizio 100 Series Systems with Confocal MiniprobesOWN · Traditional | 08/04/2017SE |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesOWN · Special | 05/20/2016SE |
| K150831 | Cellvizio 100 Series System with Confocal MiniprobesOWN · Traditional | 12/22/2015SE |
Questions and answers
When was Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes cleared by the FDA?
Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes (K120208) received a 510(k) decision of Substantially Equivalent on April 20, 2012, 87 days after the submission was received.
What is the product code of K120208?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.