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FDA 510(k)

DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9

K-Number: K073056 · 2007-11-13

ApplicantVieworks Co., Ltd.
Decision Date2007-11-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 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 2007-11-13 under 510(k) number K073056. 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 DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9?

DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 is a medical device that received FDA 510(k) clearance on 2007-11-13. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K073056.

When did DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 received FDA 510(k) clearance on 2007-11-13, under 510(k) number K073056.

Who is the listed applicant for DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9?

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-9?

The FDA product code for DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 is MQB.

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Other records listing Vieworks Co., Ltd. as applicant

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K260820VIVIX-S 4386W (FXRD-4386WA)K254092Bellalun 2D (VDMS-1000S)K251410VXvueK241113VIVIX-MK241125VIVIX-S 1751SK220239Solid State X-ray Imager(Model: FXRD-4386WB)

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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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