510(k) K150018 ยท OWN Confocal Optical Imaging
VS3-IR-MMS System
| Applicant | Visionsense, Ltd., Petach Tikva, Hamerkaz, IL |
| Decision | Substantially Equivalent, Jun 17, 2015 |
| Received | Jan 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR)
Product Number: 174-0012 Open, Classified |
OWN | None listed |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm
Product Number: 175-0012 Open, Classified |
OWN | None listed |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)
Product Number: 161-0001 Open, Classified |
OWN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.