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FDA 510(k)

VIZION DR

K-Number: K102123 · 2011-01-24

ApplicantViztek, Inc.
Decision Date2011-01-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIZION DR is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, Inc.. It received FDA 510(k) clearance on 2011-01-24 under 510(k) number K102123. The device is classified under product code KPR. 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 2011-01-24. The listed applicant is Viztek, Inc.. The 510(k) number is K102123.

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

VIZION DR received FDA 510(k) clearance on 2011-01-24, under 510(k) number K102123.

Who is the listed applicant for VIZION DR?

The FDA 510(k) record lists Viztek, Inc. 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 KPR.

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.

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Other records listing Viztek, Inc. 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.

K091752VIZTEK WLK082604VIZTEK DR, MODELS: DR1000, DR3000, DR4000K063337OPAL-RADK003607ONYX-RAD TELEMEDICINE PACS

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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.

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