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IMAGE DIAGNOSTICS, INC.

USA · Fitchburg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 4Class II 3Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 3 510(k), 0 PMA, 47 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia2 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: IMAGE DIAGNOSTICS, INC. · Image Diagnostics Inc.

FDA 510(k) clearances by year

21994 · K944772

11995 · K950631

FDA listed device types

Screen, Leaded, Operator Radiation Protector 1System, Digital Image Communications, Radiological 1Barrier, Control Panel, X-Ray, Movable 1Board, Arm (With Cover), Non-Sterile 1Table, Radiographic, Non-Tilting, Powered 1Table, Cystometric, Electric 1Table, Radiographic, Tilting 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K950631	ID400 SERIES ARMBOARDS	1995-03-24
US	K944772	MULTIPLE ED1600 SERIES RADIATION SHIELDS	1994-10-20
US	K942190	ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE	1994-08-17
SA	ME0000016437SFDAA00002	Mobile Video Cart	—
SA	ME0000016437SFDAA00003	Mobile Imaging Table	—

IMAGE DIAGNOSTICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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