Insight Enhanced™ DRF (EN-1002-01)
K号: K251650 · 2025-09-16
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器械摘要
Insight Enhanced™ DRF (EN-1002-01) is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2025-09-16 under 510(k) number K251650. 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 Insight Enhanced™ DRF (EN-1002-01)?
Insight Enhanced™ DRF (EN-1002-01) is a medical device that received FDA 510(k) clearance on 2025-09-16. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K251650.
When did Insight Enhanced™ DRF (EN-1002-01) receive FDA 510(k) clearance?
Insight Enhanced™ DRF (EN-1002-01) received FDA 510(k) clearance on 2025-09-16, under 510(k) number K251650.
Who is the listed applicant for Insight Enhanced™ DRF (EN-1002-01)?
The FDA 510(k) record lists Imaging Engineering, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insight Enhanced™ DRF (EN-1002-01)?
The FDA product code for Insight Enhanced™ DRF (EN-1002-01) is JAA.
相关临床试验
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列明Imaging Engineering, LLC为申报人的其他记录
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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 CorporationK242488Soteria 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 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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