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Medical Standard Co., Ltd.

Country not established FDA

Devices
3
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Medical Standard Co., Ltd. makes

Medical Standard Co., Ltd. makes PACS (Picture Archiving and Communication System) software products, including PACSPLUS, PACSPARTNER, and PACS PLUS 5TH EDITION, which are used for storing, retrieving, managing, and distributing medical imaging data.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Pacsplus Ref K023460

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Pacspartner Ref K042311

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Pacs Plus 5TH Edition Ref K083658

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Medical Standard Co., Ltd. Songpa-gu Seoul · KR FEI 3003941243

Frequently asked questions

How many devices does Medical Standard Co., Ltd. have in the registry?

The registry currently lists 3 devices for Medical Standard Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medical Standard Co., Ltd.'s devices?

Among its 3 most recently registered devices, Medical Standard Co., Ltd. has devices listed in FDA 510(k) (3 devices).

What risk classes do Medical Standard Co., Ltd.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Medical Standard Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Medical Standard Co., Ltd. in the registry?

The most recently registered devices listed for Medical Standard Co., Ltd. include PACSPLUS, PACSPARTNER and PACS PLUS 5TH EDITION.

Which FDA establishments are linked to Medical Standard Co., Ltd.?

1 FDA establishment is linked to Medical Standard Co., Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.