Orthopantomograph® OP 3D LX
K号: K230505 · 2023-06-09
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器械摘要
Orthopantomograph™ OP 3D LX is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230505. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Orthopantomograph™ OP 3D LX?
Orthopantomograph™ OP 3D LX is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Palodex Group OY. The 510(k) number is K230505.
When did Orthopantomograph™ OP 3D LX receive FDA 510(k) clearance?
Orthopantomograph™ OP 3D LX received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230505.
Who is the listed applicant for Orthopantomograph™ OP 3D LX?
The FDA 510(k) record lists Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthopantomograph™ OP 3D LX?
The FDA product code for Orthopantomograph™ OP 3D LX is OAS.
相关临床试验
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列明Palodex Group OY为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OAS）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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