Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007603861

FEI Number

3007603861

Entity Name

MICHELSON DIAGNOSTICS LTD

City/State/Country

Maidstone Kent, GB

Establishment Address

Units 1 & 2 Maidstone Innovation Centre, Gidds Pond Way, Maidstone Kent ME14 5FY, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Michelson Diagnostics Ltd (Owner Number: 10031361)

Owner / Operator Contact Address

Units 1 & 2, Maidstone Innovation Centre, Gidds Pond Way, Maidstone, GB-KEN ME14 5FY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153283

PMA Number

N/A

All Registered Proprietary Names

VivoSight VivoSight Dx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2010-01-20
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2016-10-24

Official Correspondent

Jon Holmes

US Agent Details

Craig Fortier Business: Michelson Diagnostics Inc Email: fda@vivosight.com Phone: (408) 5047391

Related Public Records

Same Entity

Michelson Diagnostics Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K183320	St. Jude Medical (Now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K253459	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
K210458	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	2021-06-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007603861. Last updated year: 2026. Please use registration number 3007603861 when referencing this establishment in official correspondence.