Data / Medical devices / United Kingdom / Michelson Diagnostics Ltd
Michelson Diagnostics Ltd: FDA-registered device maker in Maidstone Kent, United Kingdom, 2 510(k) clearances
Michelson Diagnostics Ltd is registered with the FDA (registration 3007603861) in Maidstone Kent, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007603861
- Address
- Units 1 & 2 Maidstone Innovation Centre Gidds Pond Way, Maidstone Kent, United Kingdom, ME14 5FY
- Owner or operator
- Michelson Diagnostics Ltd (10031361)
- Roles
- Manufacturer
- First device listed
- January 20, 2010
- Registered through
- 2026
- Brand names listed
- VivoSight, VivoSight Dx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | 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 |
|---|---|---|---|---|---|---|
| August 11, 2016 | K153283 | VivoSight Dx Topical OCT System | NQQ | Substantially Equivalent | Michelson Diagnostics, Ltd. | accessdata.fda.gov |
| January 5, 2010 | K093520 | VIVOSIGHT TOPICAL OCT SYSTEM | NQQ | Substantially Equivalent | Michelson Diagnostics, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2016. 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.