Ray Co., Ltd.
Hwaseong-Si, KR
Ray Co., Ltd. appears in FDA device records in Hwaseong-Si, KR. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Ray Co., Ltd. between 2015 and 2021. The busiest year on record is 2018, with 3. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213226 | RCT700 | OAS | Substantially Equivalent | |
| K192737 | RCT800 | OAS | Substantially Equivalent | |
| K190812 | RAYSCAN a-Expert3D | OAS | Substantially Equivalent | |
| K182805 | RCT800 | OAS | Substantially Equivalent | |
| K182614 | RCT700 | OAS | Substantially Equivalent | |
| K181452 | RCT800 | OAS | Substantially Equivalent | |
| K160525 | RCT700 | OAS | Substantially Equivalent | |
| K160788 | RIOScan (RPS500) | MUH | Substantially Equivalent | |
| K142247 | RAYSCAN A-EXPERT 3D | OAS | Substantially Equivalent | |
| K143000 | RIS500 | MQB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain