Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)

K-Number: K201043 · 2020-05-12

ApplicantIray Technology Taicang , Ltd.
Decision Date2020-05-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) 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 2020-05-12 under 510(k) number K201043. 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 Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) is a medical device that received FDA 510(k) clearance on 2020-05-12. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K201043.

When did Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) receive FDA 510(k) clearance?

Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) received FDA 510(k) clearance on 2020-05-12, under 510(k) number K201043.

Who is the listed applicant for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

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 Panel Detector (Model: Mars1717V-VSI, Mano4343W)?

The FDA product code for Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) 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 1717VK221714Flat Panel DetectorK221345Wireless Digital Flat Panel DetectorK220536Digital flat panel detectorK220668Wireless Digital Flat Panel Detector

View all 21 devices →

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.

↑