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FDA 510(k)

VIVIX-S 4386W (FXRD-4386WA)

K-Number: K260820 · 2026-06-18

ApplicantVieworks Co., Ltd.
Decision Date2026-06-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIVIX-S 4386W (FXRD-4386WA) 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 2026-06-18 under 510(k) number K260820. 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 VIVIX-S 4386W (FXRD-4386WA)?

VIVIX-S 4386W (FXRD-4386WA) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K260820.

When did VIVIX-S 4386W (FXRD-4386WA) receive FDA 510(k) clearance?

VIVIX-S 4386W (FXRD-4386WA) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260820.

Who is the listed applicant for VIVIX-S 4386W (FXRD-4386WA)?

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 VIVIX-S 4386W (FXRD-4386WA)?

The FDA product code for VIVIX-S 4386W (FXRD-4386WA) is MQB.

Other records listing Vieworks Co., Ltd. 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.

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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.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.K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited

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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