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FDA 510(k)

VIZTEK DR, MODELS: DR1000, DR3000, DR4000

K-Number: K082604 · 2008-11-21

ApplicantViztek, Inc.
Decision Date2008-11-21
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIZTEK DR, MODELS: DR1000, DR3000, DR4000 is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, Inc.. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K082604. 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 VIZTEK DR, MODELS: DR1000, DR3000, DR4000?

VIZTEK DR, MODELS: DR1000, DR3000, DR4000 is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Viztek, Inc.. The 510(k) number is K082604.

When did VIZTEK DR, MODELS: DR1000, DR3000, DR4000 receive FDA 510(k) clearance?

VIZTEK DR, MODELS: DR1000, DR3000, DR4000 received FDA 510(k) clearance on 2008-11-21, under 510(k) number K082604.

Who is the listed applicant for VIZTEK DR, MODELS: DR1000, DR3000, DR4000?

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 VIZTEK DR, MODELS: DR1000, DR3000, DR4000?

The FDA product code for VIZTEK DR, MODELS: DR1000, DR3000, DR4000 is KPR.

Related Clinical Trials

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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.

K102123VIZION DRK091752VIZTEK WLK063337OPAL-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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