FDA 510(k)

PIXX 1717; PIXX 1417; PIXX 1212; 数字诊断X射线接收器面板

K号: K182533 · 2018-10-04

决定日期2018-10-04

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is the device name listed in this FDA 510(k) record. The listed applicant is Pixxgen Corporation. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182533. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Pixxgen Corporation. The 510(k) number is K182533.

When did PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels receive FDA 510(k) clearance?

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182533.

Who is the listed applicant for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

The FDA 510(k) record lists Pixxgen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels?

The FDA product code for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels is MQB.

列明Pixxgen Corporation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。

K211108Prudent 1717, Prudent 1417, Prudent 1212 K190691Pixx2430 数字诊断X射线接收器面板 K180976PIXX 1717; PIXX 1417; PIXX 1212; 数字诊断X射线接收器面板

官方来源

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