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STANDARD IMAGING, INC.

USA · Middleton

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Russia — 6 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

13listed device types

Class I 8Class II 5Class III 0

plus 14 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

11 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States14 registration records, 10 510(k), 0 PMA, 27 excluded

Brazil0 confirmed, 7 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada2 confirmed, 4 excluded

Manufacturer names merged into this page: STANDARD IMAGING, INC. · Standard Imaging, Inc

FDA 510(k) clearances by year

11992

11994

22000

12001

22004

12006

12008

12010

FDA listed device types

showing 8 of 13

System, Digital Image Communications, Radiological 1Device, Digital Image Storage, Radiological 1Phantom, Anthropomorphic, Radiographic 1System, Applicator, Radionuclide, Manual 1Instrument, Quality-Assurance, Radiologic 1Holder, Head, Radiographic 1Shield, Protective, Personnel 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103193	DOSEVIEW 3D	2010-12-27
US	K082773	STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331	2008-11-19
US	K060532	HDR 1000 PLUS WELL CHAMBER, MODEL 90008	2006-04-11
SA	ME0000007809SFDAA00002	MIMI Phantom	—
CA	66019	TRUMPET E.IMRT PRE-PLANNING SOFTWARE	Class II
CA	72147	THEBES II THERAPY BEAM EVALUATION SYSTEM	Class II

STANDARD IMAGING, 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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