Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016735536

FEI Number

3016735536

Entity Name

INTEGRATED OPHTHALMIC SYSTEMS, INC.

City/State/Country

Woburn, MA, US

Establishment Address

596 Main Street, Woburn, MA 01801, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Integrated Ophthalmic Systems, Inc. (Owner Number: 10069477)

Owner / Operator Contact Address

596 Main Street, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200385

PMA Number

N/A

All Registered Proprietary Names

Continuum PACS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFJ	System, Image Management, Ophthalmic	Radiology	Class 2	892.2050	2020-04-13

Official Correspondent

Matthew Carnevale

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integrated Ophthalmic Systems, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016735536. Last updated year: 2026. Please use registration number 3016735536 when referencing this establishment in official correspondence.