FDA 510(k)

필립스 멀티스라이스 CT 시스템과 저선량 CT 폐암

K-번호: K153444 · 2016-04-08

신청자Philips Medical Systems (Cleveland), Inc.

결정일2016-04-08

제품 코드JAK

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

결정대체적으로 동일

기기 요약

Philips Multislice CT System with Low Dose CT Lung Cancer is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153444. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Philips Multislice CT System with Low Dose CT Lung Cancer?

Philips Multislice CT System with Low Dose CT Lung Cancer is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K153444.

When did Philips Multislice CT System with Low Dose CT Lung Cancer receive FDA 510(k) clearance?

Philips Multislice CT System with Low Dose CT Lung Cancer received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153444.

Who is the listed applicant for Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer?

The FDA product code for Philips Multislice CT System with Low Dose CT Lung Cancer is JAK.

Philips Medical Systems (Cleveland), Inc.를 신청인으로 등재한 기타 기록

K171850필립스 CT Big Bore K172406인기우 TF K162838필립스 iCT CT 시스템 K163711IQon 스펙트럴 CT K170086피닉스 방사선 치료 계획 시스템 K160743필립스 인기너시 CT

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