Soteria E-View
K号: K242488 · 2025-01-06
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器械摘要
Soteria E-View is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2025-01-06 under 510(k) number K242488. 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 Soteria E-View?
Soteria E-View is a medical device that received FDA 510(k) clearance on 2025-01-06. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K242488.
When did Soteria E-View receive FDA 510(k) clearance?
Soteria E-View received FDA 510(k) clearance on 2025-01-06, under 510(k) number K242488.
Who is the listed applicant for Soteria E-View?
The FDA 510(k) record lists Omega Medical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Soteria E-View?
The FDA product code for Soteria E-View is JAA.
相关临床试验
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列明Omega Medical Imaging, LLC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, 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 GmbHK232910CombiDiagnost R90Philips 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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