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DK MEDICAL SYSTEMS CO., LTD.

Korea, Republic · Pyeongtaek-Si Gyeonggi

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, Israel — 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

5listed device types

Class I 2Class II 3Class III 0

plus 7 registration records and 4 510(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

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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, 4 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 2 excluded

Manufacturer names merged into this page: DK MEDICAL SYSTEMS CO., LTD.

FDA 510(k) clearances by year

32025 · K250790

12026 · K253446

FDA listed device types

System, X-Ray, Stationary 1Table, Radiographic, Non-Tilting, Powered 1System, X-Ray, Mobile 1Holder, Radiographic Cassette, Wall-Mounted 1Tube Mount, X-Ray, Diagnostic 1

Market	Identifier	Name	Class / date
US	K253446	AeroDR TX c02	2026-04-10
US	K250790	INNOVISION-DXII	2025-08-01
US	K250750	INNOVISION-P5	2025-07-18

DK MEDICAL SYSTEMS CO., LTD.

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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