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FDA 510(k)

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

K-Number: K231467 · 2023-06-21

ApplicantRayence Co., Ltd.
Decision Date2023-06-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF 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 2023-06-21 under 510(k) number K231467. 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 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K231467.

When did 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF receive FDA 510(k) clearance?

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231467.

Who is the listed applicant for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

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 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?

The FDA product code for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF 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.

K2538000909FCE, 0909FCE-HSK2438492430TCA with Xmaru WK242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)K2403710909FCC, 0909FCC-HSK220689Vatech 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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.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.

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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