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FDA 510(k)

Flat Panel Detector

K-Number: K201591 · 2020-09-03

ApplicantKa Imaging, Inc.
Decision Date2020-09-03
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 Ka Imaging, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K201591. 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 2020-09-03. The listed applicant is Ka Imaging, Inc.. The 510(k) number is K201591.

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

Flat Panel Detector received FDA 510(k) clearance on 2020-09-03, under 510(k) number K201591.

Who is the listed applicant for Flat Panel Detector?

The FDA 510(k) record lists Ka Imaging, Inc. 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

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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