FDA 510(k)

PRORAD ATLAS 超便携式；PRORAD ATLAS 超便携式 PLUS

K号: K243473 · 2025-07-29

申请人Prognosys Medical Systems Private Limited

决定日期2025-07-29

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K243473. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K243473.

When did PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS receive FDA 510(k) clearance?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS received FDA 510(k) clearance on 2025-07-29, under 510(k) number K243473.

Who is the listed applicant for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

The FDA 510(k) record lists Prognosys Medical Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

The FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is IZL.

列明Prognosys Medical Systems Private Limited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。

K240771PRORAD X射线平板探测器带DROC K183541ProRad 2FC和ProRad 3NC固定式X光摄影系统

官方来源

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