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FDA 510(k)

Digital Radiography System (ManntiX B, ManntiX K)

K-Number: K240841 · 2024-12-09

ApplicantShenzhen Browiner Tech Co., Ltd.
Decision Date2024-12-09
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Radiography System (ManntiX B, ManntiX K) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K240841. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Radiography System (ManntiX B, ManntiX K)?

Digital Radiography System (ManntiX B, ManntiX K) is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. The 510(k) number is K240841.

When did Digital Radiography System (ManntiX B, ManntiX K) receive FDA 510(k) clearance?

Digital Radiography System (ManntiX B, ManntiX K) received FDA 510(k) clearance on 2024-12-09, under 510(k) number K240841.

Who is the listed applicant for Digital Radiography System (ManntiX B, ManntiX K)?

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

What is the FDA product code for Digital Radiography System (ManntiX B, ManntiX K)?

The FDA product code for Digital Radiography System (ManntiX B, ManntiX K) is IZL.

Other records listing Shenzhen Browiner Tech 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.

K240284Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom 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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