VS3-IR system
FDA 510(k) K152204 · Visionsense, Ltd.
510(k) numberK152204
Submission
- Device name
- VS3-IR system
- Applicant
- Visionsense, Ltd.
Petach Tikva, Hamerkaz, IL - Received
- August 6, 2015
- Decision date
- October 28, 2015
- 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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More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K223020 | VS3-Iridium System (VS3-IR)OWN · Special | 10/28/2022SE |
| K210265 | VS3 Iridium SytemOWN · Traditional | 11/22/2021SE |
| K171208 | Trans-anal IntroducerFED · Traditional | 02/05/2018SE |
| K153548 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 02/22/2016SE |
| K150018 | VS3-IR-MMS SystemOWN · Traditional | 06/17/2015SE |
| K141002 | VS3 Stereoscopic High Definition Vision SystemHRX · Traditional | 06/26/2014SE |
| K131434 | VS3 Stereoscopic High Definition Vision SystemGWG · Special | 07/16/2013SE |
| K123467 | VS3GCJ · Special | 04/17/2013SE |
| K082355 | Visionsense Stereoscopic Vision SystemHRX · Traditional | 12/15/2008SE |
| K082667 | Visionsense Stereoscopic Vision System (VS System)EOB · Traditional | 10/30/2008SE |
Questions and answers
When was VS3-IR system cleared by the FDA?
VS3-IR system (K152204) received a 510(k) decision of Substantially Equivalent on October 28, 2015, 83 days after the submission was received.
What is the product code of K152204?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.