MammoSTAR活检位点标识器
K号: K251748 · 2025-07-23
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决定日期2025-07-23
产品代码NEU
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
MammoSTAR Biopsy Site Identifier is the device name listed in this FDA 510(k) record. The listed applicant is Carbon Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K251748. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MammoSTAR Biopsy Site Identifier?
MammoSTAR Biopsy Site Identifier is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Carbon Medical Technologies, Inc.. The 510(k) number is K251748.
When did MammoSTAR Biopsy Site Identifier receive FDA 510(k) clearance?
MammoSTAR Biopsy Site Identifier received FDA 510(k) clearance on 2025-07-23, under 510(k) number K251748.
Who is the listed applicant for MammoSTAR Biopsy Site Identifier?
The FDA 510(k) record lists Carbon Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MammoSTAR Biopsy Site Identifier?
The FDA product code for MammoSTAR Biopsy Site Identifier is NEU.
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。
列明Carbon Medical Technologies, Inc.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：NEU）
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。
K253761HydroMARK™ Plus 乳腺活检位点标记（蜻蜓形状）；HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）Devicor Medical Products, Inc.K253888MOLLI 2 系统Stryker EndoscopyK252892SCOUT MD 外科引导系统Merit Medical Systems, Inc.K251989VizMark 预装组织标记器设备（VM-0001）Breast-Med, Inc.K243642UltraCor™ Twirl™ 乳腺组织标记器Bard Peripheral Vascular, Inc.K233639SmartClip 安全软组织标记Elucent Medical, Inc.
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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