FDA 510(k)

피닉스 방사선 치료 계획 시스템

K-번호: K170086 · 2017-02-09

신청자Philips Medical Systems (Cleveland), Inc.

결정일2017-02-09

제품 코드MUJ

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

결정대체적으로 동일

기기 요약

Pinnacle Radiation Therapy Planning System 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 2017-02-09 under 510(k) number K170086. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pinnacle Radiation Therapy Planning System?

Pinnacle Radiation Therapy Planning System is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K170086.

When did Pinnacle Radiation Therapy Planning System receive FDA 510(k) clearance?

Pinnacle Radiation Therapy Planning System received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170086.

Who is the listed applicant for Pinnacle Radiation Therapy Planning System?

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 Pinnacle Radiation Therapy Planning System?

The FDA product code for Pinnacle Radiation Therapy Planning System is MUJ.

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

K171850필립스 CT Big Bore K172406인기우 TF K162838필립스 iCT CT 시스템 K163711IQon 스펙트럴 CT K160743필립스 인기너시 CT K153444필립스 멀티스라이스 CT 시스템과 저선량 CT 폐암

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