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FDA 510(k)

Flat Panel Detector

K-Number: K221714 · 2022-06-29

ApplicantIray Technology Taicang , Ltd.
Decision Date2022-06-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Flat Panel 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 2022-06-29 under 510(k) number K221714. 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 Flat Panel Detector?

Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K221714.

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

Flat Panel Detector received FDA 510(k) clearance on 2022-06-29, under 510(k) number K221714.

Who is the listed applicant for Flat Panel 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 Flat Panel Detector?

The FDA product code for Flat Panel Detector is MQB.

Related Clinical Trials

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.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

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 1717VK221345Wireless Digital Flat Panel DetectorK220536Digital flat panel detectorK220668Wireless Digital Flat Panel DetectorK213646Focus HD 35 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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