FDA 510(k)

안과 소프트웨어 플랫폼 RX

K-번호: K173689 · 2018-02-23

결정일2018-02-23

제품 코드NFJ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Ophthalmic Software Platform RX is the device name listed in this FDA 510(k) record. The listed applicant is Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173689. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ophthalmic Software Platform RX?

Ophthalmic Software Platform RX is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Canon Inc. -Medical Equipment Group. The 510(k) number is K173689.

When did Ophthalmic Software Platform RX receive FDA 510(k) clearance?

Ophthalmic Software Platform RX received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173689.

Who is the listed applicant for Ophthalmic Software Platform RX?

The FDA 510(k) record lists Canon Inc. -Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ophthalmic Software Platform RX?

The FDA product code for Ophthalmic Software Platform RX is NFJ.

Canon Inc. -Medical Equipment Group를 신청인으로 등재한 기타 기록

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