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FDA 510(k)

DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA

K-Number: K122919 · 2013-01-01

ApplicantRayence Co., Ltd.
Decision Date2013-01-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA 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 2013-01-01 under 510(k) number K122919. 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 DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA?

DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA is a medical device that received FDA 510(k) clearance on 2013-01-01. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K122919.

When did DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA receive FDA 510(k) clearance?

DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA received FDA 510(k) clearance on 2013-01-01, under 510(k) number K122919.

Who is the listed applicant for DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA?

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 DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA?

The FDA product code for DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA is MQB.

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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-HSK2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFK220689Vatech Clismile

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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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