FDA 510(k)

dSセンチネルブスト16ch 3.0Tコイル

K番号: K213727 · 2022-08-08

申請者Invivo Corporation (Business Trade Name: Philips)

決定日2022-08-08

製品コードMOS

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

dS Sentinelle Breast 16ch 3.0T 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 K213727. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the dS Sentinelle Breast 16ch 3.0T Coil?

dS Sentinelle Breast 16ch 3.0T 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 K213727.

When did dS Sentinelle Breast 16ch 3.0T Coil receive FDA 510(k) clearance?

dS Sentinelle Breast 16ch 3.0T Coil received FDA 510(k) clearance on 2022-08-08, under 510(k) number K213727.

Who is the listed applicant for dS Sentinelle Breast 16ch 3.0T 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 3.0T Coil?

The FDA product code for dS Sentinelle Breast 16ch 3.0T Coil is MOS.

申請者としてInvivo Corporation (Business Trade Name: Philips)を記載するその他の記録

K232762dSブストコイル7ch 1.5T K2223258ch 手首コイル K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K213735dSセンチネルブスト16ch 1.5Tコイル K213351ds ヘッド 32ch 3.0T

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