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FDA 510(k)

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16

K-Number: K080553 · 2008-04-16

ApplicantVieworks Co., Ltd.
Decision Date2008-04-16
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080553. 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 DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16?

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K080553.

When did DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080553.

Who is the listed applicant for DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16?

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

What is the FDA product code for DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16?

The FDA product code for DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 is KPR.

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Related Devices (Code: KPR)

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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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