VivoSight Dx Topical OCT System
Michelson Diagnostics Ltd
MICHELSON DIAGNOSTICS LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007603861 | 3007603861 | MICHELSON DIAGNOSTICS LTD | 1 | N | 2026-01-01 | Units 1 & 2 Maidstone Innovation Centre Gidds Pond Way Maidstone Kent GB ME14 5FY |
| 3009244981 | 3009244981 | MICHELSON DIAGNOSTICS, INC. | 1 | Y | 2026-01-01 | 5444 Santa Fe Road Atascadero CA US 93422 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 113024 | 1103271535 | K153283 | VivoSight Dx Topical OCT System | NQQ | 2016-08-11 |
| 113024 | 1197578640 | K093520 | VIVOSIGHT TOPICAL OCT SYSTEM | NQQ | 2010-01-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NQQ | 4 | 2016-08-11 |
PMN#
VIVOSIGHT TOPICAL OCT SYSTEM
MICHELSON DIAGNOSTICS LTD.
GUDID#
VivoSight - The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
2016-11-14
VivoSight - The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
2016-11-14