VS3-IR-MMS System
FDA 510(k) clearance K150018 · decided 2015-06-17
Clearance details
- K-number
- K150018
- Device name
- VS3-IR-MMS System
- Applicant
- Visionsense, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-05
- Decision date
- 2015-06-17
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Petach Tikva, Hamerkaz, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product N recall (Z-0280-2023) | Visionsense, Ltd. | 2022-11-23 |
| VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Pr recall (Z-0281-2023) | Visionsense, Ltd. | 2022-11-23 |
| VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Produc recall (Z-0282-2023) | Visionsense, Ltd. | 2022-11-23 |