caliberid.comVivaScope System
Caliber Imaging & Diagnostics, Inc.
Caliber Imaging & Diagnostics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1320925 | 3001451602 | Caliber Imaging & Diagnostics, Inc. | 1 | N | 2026-01-01 | 50 Methodist Hill Dr Ste 1000 ROCHESTER NY US 14623 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860292000306 | VivaScope System - The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,and software that captures images of in vivo tissue specimens from the exposed surface of thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels. | 5857582816 | cmalessi@caliberid.com |
| 00860292000306 | VivaScope System - The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,and software that captures images of in vivo tissue specimens from the exposed surface of thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels. | +1 (585) 758-2826 | jradford@caliberid.com |
| 08602920003035 | VivaScope 2500 - The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that are stained with fluorochromes that fluoresce when illuminated with a laser. The VivaScope 2500 is used by physicians and other licensed healthcare professionals to view enlarged images of specimens during pathological examinations. | +1 (585) 758-2826 | jradford@caliberid.com |
| 08602920003066 | VivaScope System - The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,and software that captures images of in vivo tissue specimens from the exposed surface of thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels. | +1 (585) 758-2826 | jradford@caliberid.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53251 | 1516730038 | K180162 | VivaScope System | PSN | 2018-05-03 |
| 53251 | 1431403187 | K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | PSN | 2008-09-17 |
| 53251 | 1205411291 | ||||
| 53251 | 1741852800 | ||||
| 53251 | 1833459222 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PSN | 2 | 2018-05-03 |
PMN#
GUDID#
VivaScope 2500 - The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that are stained with fluorochromes that fluoresce when illuminated with a laser. The VivaScope 2500 is used by physicians and other licensed healthcare professionals to view enlarged images of specimens during pathological examinations.
2023-02-16
VivaScope System - The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,and software that captures images of in vivo tissue specimens from the exposed surface of thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels.
2023-02-16
VivaScope System - The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager,and software that captures images of in vivo tissue specimens from the exposed surface of thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels.
2016-08-22