Data / Medical devices / United States / Caliber Imaging & Diagnostics, Inc.
Caliber Imaging & Diagnostics, Inc.: FDA-registered device maker in Rochester, NY, United States, 2 510(k) clearances
Caliber Imaging & Diagnostics, Inc. is registered with the FDA (registration 1320925) in Rochester, NY, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 3, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1320925
- FEI number
- 3001451602
- Address
- 50 Methodist Hill Dr Ste 1000, Rochester, NY, United States, 14623
- Owner or operator
- Caliber ID (9029726)
- Roles
- Manufacturer
- First device listed
- December 10, 1999
- Registered through
- 2026
- Brand names listed
- VivaNet, VivaScope, VivaScope 1500, VivaScope 2500, VivaScope 3000, VivaScope System, VivaScope System, VivaScope, VivaScope 1500, VivaScope 3000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Light Based Imaging | PSN | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Fluorescence/U.V. | IBK | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Phase Contrast | IBM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2018 | K180162 | VivaScope System | PSN | Substantially Equivalent | Caliber Imaging & Diagnostics, Inc. | accessdata.fda.gov |
| September 17, 2008 | K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | PSN | Substantially Equivalent | Lucid, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Imaging
- All makers of Device, Digital Image Storage, Radiological
- All makers of Microscope, Fluorescence/U.V.
- All makers of Microscope, Phase Contrast
Updated May 3, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.