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FDA 510(k)

0909FCE, 0909FCE-HS

K-Number: K253800 · 2026-07-31

ApplicantRayence Co., Ltd.
Decision Date2026-07-31
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

0909FCE, 0909FCE-HS is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K253800. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0909FCE, 0909FCE-HS?

0909FCE, 0909FCE-HS is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K253800.

When did 0909FCE, 0909FCE-HS receive FDA 510(k) clearance?

0909FCE, 0909FCE-HS received FDA 510(k) clearance on 2026-07-31, under 510(k) number K253800.

Who is the listed applicant for 0909FCE, 0909FCE-HS?

The FDA 510(k) record lists Rayence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0909FCE, 0909FCE-HS?

The FDA product code for 0909FCE, 0909FCE-HS is MQB.

Other records listing Rayence Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2438492430TCA with Xmaru WK242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)K2403710909FCC, 0909FCC-HSK2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFK220689Vatech ClismileK2127530909FCB, 1212FCA

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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