0909FCE, 0909FCE-HS— 510(k) K253800
Substantially EquivalentRayence Co., Ltd.
FDA 510(k) clearance K253800 for 0909FCE, 0909FCE-HS, Substantially Equivalent on 2026-07-31. Applicant: Rayence Co., Ltd.. Device class: 2.
Summary
Rayence's 0909FCE and 0909FCE-HS are filed under MQB, solid state X-ray imagers (flat panel or digital imagers). The names are model designations, and the record doesn't give specs for either.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Rayence filed from Hwaseong-si, South Korea. Review took 245 calendar days (November 28, 2025 to July 31, 2026).
Clearance details
- Applicant
- Rayence Co., Ltd.
- Product code
- Product code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hwaseong-Si, KR
Recent devices under product code MQB
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