铂金 dRF 成像系统
K号: K160301 · 2016-03-04
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器械摘要
Platinum dRF Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Apelem-Dms Group. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K160301. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Platinum dRF Imaging System?
Platinum dRF Imaging System is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Apelem-Dms Group. The 510(k) number is K160301.
When did Platinum dRF Imaging System receive FDA 510(k) clearance?
Platinum dRF Imaging System received FDA 510(k) clearance on 2016-03-04, under 510(k) number K160301.
Who is the listed applicant for Platinum dRF Imaging System?
The FDA 510(k) record lists Apelem-Dms Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Platinum dRF Imaging System?
The FDA product code for Platinum dRF Imaging System is JAA.
相关临床试验
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列明Apelem-Dms Group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：JAA）
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。
K253103Nexus DRF 数字X射线成像系统Varex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT 移动荧光透视系统Dornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH
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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