FDA 510(k)

dSブストコイル7ch 1.5T

K番号: K232762 · 2023-10-03

申請者Invivo Corporation (Business Trade Name: Philips)

決定日2023-10-03

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 Breast Coil 7ch 1.5T 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 2023-10-03 under 510(k) number K232762. 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 Breast Coil 7ch 1.5T?

dS Breast Coil 7ch 1.5T is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Invivo Corporation (Business Trade Name: Philips). The 510(k) number is K232762.

When did dS Breast Coil 7ch 1.5T receive FDA 510(k) clearance?

dS Breast Coil 7ch 1.5T received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232762.

Who is the listed applicant for dS Breast Coil 7ch 1.5T?

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 Breast Coil 7ch 1.5T?

The FDA product code for dS Breast Coil 7ch 1.5T 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

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 K213727dSセンチネルブスト16ch 3.0Tコイル K213351ds ヘッド 32ch 3.0T

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。