FDA 510(k)

牙科锥形束计算机断层扫描（FinScan F350）

K号: K242805 · 2025-01-09

申请人Changzhou Finno Medical Technology Co., Ltd.

决定日期2025-01-09

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

Dental Cone-beam Computed Tomography (FinScan F350) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-09 under 510(k) number K242805. 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 Dental Cone-beam Computed Tomography (FinScan F350)?

Dental Cone-beam Computed Tomography (FinScan F350) is a medical device that received FDA 510(k) clearance on 2025-01-09. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. The 510(k) number is K242805.

When did Dental Cone-beam Computed Tomography (FinScan F350) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (FinScan F350) received FDA 510(k) clearance on 2025-01-09, under 510(k) number K242805.

Who is the listed applicant for Dental Cone-beam Computed Tomography (FinScan F350)?

The FDA 510(k) record lists Changzhou Finno Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone-beam Computed Tomography (FinScan F350)?

The FDA product code for Dental Cone-beam Computed Tomography (FinScan F350) is OAS.

官方来源

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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。

牙科锥形束计算机断层扫描（FinScan F350）

器械摘要

常见问题

相关临床试验

相关器械（代码：OAS）

官方来源