Data / Medical devices / South Korea / Medical Standard Co., Ltd.
Medical Standard Co., Ltd.: FDA-registered device maker in Songpa-gu Seoul, South Korea, 3 510(k) clearances
Medical Standard Co., Ltd. is registered with the FDA (registration 3003941243) in Songpa-gu Seoul, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 7, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003941243
- Address
- 701 MK Tower, 67, Jeongui-ro, Songpa-gu Seoul, South Korea, 05835
- Owner or operator
- MEDICAL STANDARD CO., LTD. (9053371)
- Roles
- Manufacturer
- First device listed
- March 6, 2008
- Registered through
- 2026
- Brand names listed
- PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2009 | K083658 | PACS PLUS 5TH EDITION | LLZ | Substantially Equivalent | Medical Standard Co., Ltd. | accessdata.fda.gov |
| September 9, 2004 | K042311 | PACSPARTNER | LLZ | Substantially Equivalent | Medical Standard Co., Ltd. | accessdata.fda.gov |
| January 9, 2003 | K023460 | PACSPLUS | LLZ | Substantially Equivalent | Medical Standard Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.