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 a medical device manufactured by Shenzhen Browiner Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-12-09 under approval 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. It is manufactured by Shenzhen Browiner Tech Co., Ltd.. The 510(k) number is K240841.
When was Digital Radiography System (ManntiX B, ManntiX K) approved by the FDA?
Digital Radiography System (ManntiX B, ManntiX K) received FDA 510(k) clearance on 2024-12-09, under approval number K240841.
What company makes Digital Radiography System (ManntiX B, ManntiX K)?
Digital Radiography System (ManntiX B, ManntiX K) is manufactured by Shenzhen Browiner Tech Co., Ltd..
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.
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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.