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FDA 510(k)

VIZION + DR

K-Number: K123644 · 2013-01-11

ApplicantViztek, LLC
Decision Date2013-01-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIZION + DR is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, LLC. It received FDA 510(k) clearance on 2013-01-11 under 510(k) number K123644. 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?

VIZION + DR is a medical device that received FDA 510(k) clearance on 2013-01-11. The listed applicant is Viztek, LLC. The 510(k) number is K123644.

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

VIZION + DR received FDA 510(k) clearance on 2013-01-11, under 510(k) number K123644.

Who is the listed applicant for VIZION + DR?

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?

The FDA product code for VIZION + DR is MQB.

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Other records listing Viztek, LLC 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.

K160810ViZion DR + WirelessK112661VIZION DR

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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