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FDA 510(k)

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

K-Number: K160620 · 2016-03-30

ApplicantVisaris D.O.O. Belgrade
Decision Date2016-03-30
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is the device name listed in this FDA 510(k) record. The listed applicant is Visaris D.O.O. Belgrade. It received FDA 510(k) clearance on 2016-03-30 under 510(k) number K160620. 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 Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is a medical device that received FDA 510(k) clearance on 2016-03-30. The listed applicant is Visaris D.O.O. Belgrade. The 510(k) number is K160620.

When did Visaris Vision® (Vision C, Vision U. Vision V, Vision X) receive FDA 510(k) clearance?

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) received FDA 510(k) clearance on 2016-03-30, under 510(k) number K160620.

Who is the listed applicant for Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

The FDA 510(k) record lists Visaris D.O.O. Belgrade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

The FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is KPR.

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.

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 HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems Co. , Ltd.

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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