FDA 510(k)

dS Sentinelle Breast 16ch 1.5T Coil

K-번호: K213735 · 2022-08-08

신청자Invivo Corporation (Business Trade Name: Philips)

결정일2022-08-08

제품 코드MOS

자문 위원회RA

결정Substantially Equivalent

기기 요약

dS Sentinelle Breast 16ch 1.5T Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation (Business Trade Name: Philips). It received FDA 510(k) clearance on 2022-08-08 under 510(k) number K213735. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the dS Sentinelle Breast 16ch 1.5T Coil?

dS Sentinelle Breast 16ch 1.5T Coil is a medical device that received FDA 510(k) clearance on 2022-08-08. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K213735.

When did dS Sentinelle Breast 16ch 1.5T Coil receive FDA 510(k) clearance?

dS Sentinelle Breast 16ch 1.5T Coil received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213735.

Who is the listed applicant for dS Sentinelle Breast 16ch 1.5T Coil?

The FDA 510(k) record lists Invivo Corporation (Business Trade Name: Philips) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dS Sentinelle Breast 16ch 1.5T Coil?

The FDA product code for dS Sentinelle Breast 16ch 1.5T Coil is MOS.

Invivo Corporation (Business Trade Name: Philips)를 신청인으로 등재한 기타 기록

K232762dS Breast Coil 7ch 1.5T K2223258ch 손목 코일 K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213727dS Sentinelle Breast 16ch 3.0T Coil K213351ds Head 32ch 3.0T

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