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FDA 510(k)

1717SGC_127um and 1717SGC_140um

K-Number: K171419 · 2017-06-09

ApplicantRayence Co., Ltd.
Decision Date2017-06-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1717SGC_127um and 1717SGC_140um 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 2017-06-09 under 510(k) number K171419. 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 1717SGC_127um and 1717SGC_140um?

1717SGC_127um and 1717SGC_140um is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K171419.

When did 1717SGC_127um and 1717SGC_140um receive FDA 510(k) clearance?

1717SGC_127um and 1717SGC_140um received FDA 510(k) clearance on 2017-06-09, under 510(k) number K171419.

Who is the listed applicant for 1717SGC_127um and 1717SGC_140um?

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 1717SGC_127um and 1717SGC_140um?

The FDA product code for 1717SGC_127um and 1717SGC_140um 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-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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