FDA 510(k)

ViZion DR + Wireless

K-Number: K160810 · 2016-05-20

Decision Date2016-05-20

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ViZion DR + Wireless is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, LLC. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160810. 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 ViZion DR + Wireless?

ViZion DR + Wireless is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Viztek, LLC. The 510(k) number is K160810.

When did ViZion DR + Wireless receive FDA 510(k) clearance?

ViZion DR + Wireless received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160810.

Who is the listed applicant for ViZion DR + Wireless?

The FDA 510(k) record lists Viztek, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViZion DR + Wireless?

The FDA product code for ViZion DR + Wireless is MQB.

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) Limited K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.