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Summit Industries, Inc.

USA · Niles

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

8listed device types

Class I 3Class II 5Class III 0

plus 8 registration records and 8 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States8 registration records, 8 510(k), 0 PMA, 34 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: SUMMIT INDUSTRIES, LLC

FDA 510(k) clearances by year

41985 · K851440

11987 · K874687

11988 · K874908

12016 · K153119

12018 · K173823

FDA listed device types

Table, Radiographic, Non-Tilting, Powered 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Stationary 1Table, Radiographic, Stationary Top 1Collimator, Manual, Radiographic 1Holder, Radiographic Cassette, Wall-Mounted 1Generator, High-Voltage, X-Ray, Diagnostic 1Tube Mount, X-Ray, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173823	Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System	2018-02-09
US	K153119	Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,	2016-03-14
US	K874908	C900 X-RAY FILM PROCESSOR	1988-02-12

Summit Industries, 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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