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FDA 510(k)

Wireless Digital Flat Detector

K-Number: K183713 · 2019-01-09

ApplicantIray Technology Taicang , Ltd.
Decision Date2019-01-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Digital Flat Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K183713. 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 Wireless Digital Flat Detector?

Wireless Digital Flat Detector is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K183713.

When did Wireless Digital Flat Detector receive FDA 510(k) clearance?

Wireless Digital Flat Detector received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183713.

Who is the listed applicant for Wireless Digital Flat Detector?

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

What is the FDA product code for Wireless Digital Flat Detector?

The FDA product code for Wireless Digital Flat Detector is MQB.

Other records listing Iray Technology Taicang , 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.

K223010Portable X-ray SystemK222886Mercu 1717VK221714Flat Panel DetectorK221345Wireless Digital Flat Panel DetectorK220536Digital flat panel detectorK220668Wireless Digital Flat Panel Detector

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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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