Samsung Sds Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Samsung Sds Co., Ltd.” (first 1999, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| LMD | System, Digital Image Communications, Radiological | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Samsung Sds Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002062 | SAMSUNG 10DR IMPLANT SYSTEM | EHD | 2000-11-09 | 126 |
| K992426 | RAYPAX WEB CLINICAL SYSTEM | LMD | 1999-10-13 | 84 |
| K992306 | SAMSUNG RAYPAX DISPLAY WORKSTATION | LLZ | 1999-09-22 | 75 |
| K992131 | SAMSUNG RAYPAX LONG TERM ARCHIVE | LMB | 1999-09-13 | 82 |
| K992112 | SAMSUNG RAYPAX FILM DIGITIZER | LLZ | 1999-09-09 | 79 |
| K991537 | SAMSUNG RAYPAX SYSTEM | LMD | 1999-07-06 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Samsung Sds Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Samsung Medison Co., Ltd. (73 510(k)s)
- Samsung Electronics Co., Ltd. (42 510(k)s)
- Samsung Mobile Display Co., Ltd. (5 510(k)s)
- Samsung Strategy and Innovation Center (Ssic) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Samsung Sds Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Samsung Sds Co., Ltd.” (first 1999, latest 2000), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Samsung Sds Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Samsung Sds Co., Ltd. is 80 days.
Which FDA product codes appear under Samsung Sds Co., Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 2); LMD (System, Digital Image Communications, Radiological, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Next steps
- See all 6 Samsung Sds Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Samsung Sds Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.