FDA 510(k)

頭蓋骨ナビゲーション、ナビゲーションソフトウェア頭蓋骨、顔蓋骨ナビゲーションソフトウェア、頭蓋骨EMシステム、自動登録iMRI

K番号: K223288 · 2023-07-21

決定日2023-07-21

製品コードHAW

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K223288. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI?

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Brainlab AG. The 510(k) number is K223288.

When did Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI receive FDA 510(k) clearance?

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223288.

Who is the listed applicant for Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI?

The FDA product code for Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI is HAW.