Panels › Gastroenterology, Urology › Product code OWN · Class 2
Confocal Optical Imaging
Regulation 876.1500
8510(k)s in 12 months (63 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OWN
| Company | 510(k)s | Recalls |
|---|---|---|
| Mauna Kea Technologies | 16 | 0 |
| Visionsense, Ltd. | 4 | 3 |
| KARL STORZ Endoscopy-America, Inc. | 6 | 0 |
| Stryker | 6 | 0 |
| Karl Storz SE & CO. KG | 4 | 0 |
| Novadaq Technologies Ulc. (Now A Part of Stryker) | 4 | 0 |
| Activ Surgical, Inc. | 2 | 0 |
| Medtronic | 2 | 0 |
| Olympus Medical Systems Corp. | 2 | 0 |
| SmartsurgN, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2024 | Olympus Corporation of the Americas Quest Spectrum 3 Fluorescent Imaging System
Model/Catalog Number: ART-SYS-0029, ART-SYS-0030
The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for Open, Classified |
OWN | K143474 |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner)
Product Number: 161-0001 Open, Classified |
OWN | K150018 |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm
Product Number: 175-0012 Open, Classified |
OWN | K150018 |
| Nov 23, 2022 | Visionsense, Ltd. VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR)
Product Number: 174-0012 Open, Classified |
OWN | K150018 |
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