Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1223864

FEI Number

1000305755

Entity Name

IMAGE DIAGNOSTICS, INC.

City/State/Country

Fitchburg, MA, US

Establishment Address

310 Authority Drive, Fitchburg, MA 01420, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMAGE DIAGNOSTICS, INC. (Owner Number: 9009883)

Owner / Operator Contact Address

310 AUTHORITY DRIVE, --, Fitchburg, MA 01420, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ilex Systems Connexus Systems Monitor Cart Systems MDS VAB Armboard ASPECT 100-4 ASPECT 100E ASPECT 100T ASPECT 100RTL ASPECT 100RT ASPECT ISR ASPECT 100-4T ASPECT Iso Drive Compass Flex Protego Radiation Shield System Compass Frame Compass Contour IDI Articulated Radiation Shield IDI Fixed Tabletop Radiation Shield IDI Scatter-Guard Radiation Shield Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2016-10-12
NOD	Board, Arm (With Cover), Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2014-12-09
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2011-02-22
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2002-05-07
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2020-06-04
EAK	Screen, Leaded, Operator Radiation Protector	Radiology	Class 1	892.6500	2014-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMAGE DIAGNOSTICS, INC.

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
K951176	Siemens Medical Solutions USA, Inc.	KOORDINAT M	1995-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223864. Last updated year: 2026. Please use registration number 1223864 when referencing this establishment in official correspondence.