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FDA 510(k)

MasterX 800 Series

K-Number: K230918 · 2023-09-01

ApplicantMedicatech USA
Decision Date2023-09-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MasterX 800 Series is the device name listed in this FDA 510(k) record. The listed applicant is Medicatech USA. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K230918. 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 MasterX 800 Series?

MasterX 800 Series is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Medicatech USA. The 510(k) number is K230918.

When did MasterX 800 Series receive FDA 510(k) clearance?

MasterX 800 Series received FDA 510(k) clearance on 2023-09-01, under 510(k) number K230918.

Who is the listed applicant for MasterX 800 Series?

The FDA 510(k) record lists Medicatech USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MasterX 800 Series?

The FDA product code for MasterX 800 Series is MQB.

Other records listing Medicatech USA 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.

K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)K190601MasteRad MX30

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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