Rayence Co., Ltd. FDA Record
- Latest inspection NAI · Jul 16, 2013
- No warning letters matched by name
Rayence Co., Ltd. has 0 FDA recalls, 1 inspection, 39 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Rayence Co., Ltd." is on file.
- Latest inspection
- Jul 16, 2013 · NAI
- Latest 510(k)
- Jul 31, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 39 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 16, 2013 | Hwaseong, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3009048384 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009048384 | Hwaseong, Korea (The Republic Of) | 1 | Jul 16, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | Jul 31, 2026 |
| K243849 | 2430TCA with Xmaru W | Mar 12, 2025 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Sep 9, 2024 |
| K240371 | 0909FCC, 0909FCC-HS | Mar 7, 2024 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Jun 21, 2023 |
| K220689 | Vatech Clismile | May 6, 2022 |
| K212753 | 0909FCB, 1212FCA | Oct 18, 2021 |
| K202902 | 2430MCA with Xmaru W | Jun 21, 2021 |
| K210985 | 1717FCC | Apr 28, 2021 |
| K202722 | 1212FCA | Oct 26, 2020 |
| K201796 | 1717SCV, 1717SGV | Jul 23, 2020 |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Apr 30, 2019 |
| K183478 | ClearON Mobile | Mar 1, 2019 |
| K171418 | 1417WCC_127um and1417WCC_140um | Jun 12, 2017 |
| K171417 | 1417WGC_127um and 1417WGC_140um | Jun 12, 2017 |
| K171419 | 1717SGC_127um and 1717SGC_140um | Jun 9, 2017 |
| K171420 | 1717SCC_127um and 1717SCC_140um | Jun 9, 2017 |
| K162518 | 1012WCC, 1012WGC | Oct 6, 2016 |
| K162519 | 1717WCC / 1717WGC | Oct 6, 2016 |
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | Apr 8, 2016 |
Rayence Co., Ltd. and the FDA: common questions
Has Rayence Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Rayence Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Rayence Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Rayence Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Rayence Co., Ltd.?
The most recent FDA inspection on file ended Jul 16, 2013 at Hwaseong, Korea (The Republic Of) and was classified NAI. FDA has 1 inspection of Rayence Co., Ltd. on file.
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