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Imaging Sciences International, LLC

USA · Hatfield

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 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

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 2Class III 1

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States0 registration records, 3 510(k), 0 PMA, 155 excluded

Brazil0 confirmed, 21 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada3 confirmed, 27 excluded

Manufacturer names merged into this page: IMAGING SCIENCES INTERNATIONAL, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162085	i-CAT FLX V series / KaVo 3D eXam+ V series	2016-11-10
US	K133620	CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM	2014-05-14
US	K140445	DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC	2014-04-23
CA	67727	PANOREX CMT (DENTAL X-RAY SYSTEM)	Class II
CA	67728	I-CAT 3D DENTAL IMAGING SYSTEM	Class III
CA	67729	PANOREX CMT PLUS DENTAL PANORAMIC AND TOMOGRAPHIC IMAGING SYSTEM	Class II

Imaging Sciences International, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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