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FDA 510(k)

Rotograph Prime 3D (商标为Villa Sistemi Medicali), I-MAX 3D (商标为Owandy Radiology)

K号: K180601 · 2018-11-02

申请人Villa Sistemi Medicali S.P.A.
决定日期2018-11-02
产品代码OAS
咨询委员会RA
决定实质等同

器械摘要

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180601. 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 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K180601.

When did Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) receive FDA 510(k) clearance?

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180601.

Who is the listed applicant for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

The FDA product code for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is OAS.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Villa Sistemi Medicali S.P.A.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。

K162190Rotograph Prime (商标为Villa Sistemi Medicali), I-MAX (商标为Owandy Radiology)

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。

K261748牙科锥形束计算机断层扫描（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科 X-ray 系统Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科锥形束CT系统Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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