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510(k) Premarket Notification

FDA Home Medical Devices Databases

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ProductCode: Lnh Applicant: Philips
Decision Date To: 09/27/2023

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Device Name Applicant 510(K) Decision

Number Date

Ingenia Elition R5.7.1 Sp4 Mr Systems Philips Medical Systems Nederland B.V. K232030 08/02/2023

Ingenia Elition And Mr 7700 Mr Systems Philips Medical Systems, Nederland B.V. K230972 04/28/2023

Ingenia, Ingenia Cx, Ingenia Elition, Ingenia Ambition, Mr

Philips Medical Systems Nederland B.V. K223458 04/06/2023
5300 And Mr 7700 Mr Systems

Mr 5300 And Mr 7700 R11 Mr Systems Philips Medical Systems Nederlands B.V. K223442 12/23/2022

Achieva, Ingenia, Ingenia Cx, Ingenia Elition And Ingenia

Philips Medical Systems Nederland B.V. K213583 05/16/2022
Ambition Mr Systems

Ingenia 3.0t, Ingenia 3.0t Cx, Ingenia Elition And Mr 7700

Philips Medical Systems Nederland, B.V. K213516 03/03/2022
With Distributed Multi Nudclei

Mr 5300 Philips Medical Systems Nederland B.V. K212673 11/19/2021

Invivo Corporation (Business Trade Name:

Ds Head 32ch 3.0t K213351 10/29/2021
Philips)

The Multimodality Advanced Vessel Analysis Philips Medical Systems Nederland B.V. K203216 11/25/2020

Achieva, Intera, Ingenia, Ingneia Cx, Ingenia Elition, And

Philips Medical Systems Nederland BV K193215 04/10/2020
Ingenia Ambition Mr Systems

Achieva 1.5t, 3.0t And Intera 1.5t Mr Systems Philips Medical Systems Nederland B.V. K190461 06/04/2019

Ingenia, Ingenia Cx, Ingenia Elition, And Ingenia Ambition

Philips Medical Systems Nederland B.V. K183063 02/14/2019
Mr Systems

Ingenia Ambition S And Ingenia Ambition X Philips Medical Systems Nederland B.V. K181479 08/03/2018

Prodiva 1.5t Cx And Prodiva 1.5t Cs R5.4 Philips Healthcare (Suzhou) Co., Ltd. K173507 06/15/2018

Ingenia 1.5t, Ingenia 1 5t S, Ingenia 1.5t Cx, Ingenia 3.0t

Philips Medical Systems Nederland B.V. K173079 04/04/2018
Cx R5.4

Ingenia Elition S And Ingenia Elition X Philips Medical Systems Nederland B.V. K173451 03/20/2018

Ingenia Elition S And Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V. K173356 03/06/2018

3d Apt Philips Medical Systems Nederland B.V. K172920 01/22/2018

PHILIPS MEDICAL SYSTEMS NEDERLAND

Ingenia 1.5t Cx And Ingenia 3.0t Cx R5.3 K162931 01/06/2017
B.V.

Ingenia 1.5t, Ingenia 1.5t S And Ingenia 3.0t R5.3 Philips Medical Systems Nederland B.V. K163116 01/06/2017

Multiband Sense Philips Medical Systems Nederland B.V. K162940 12/30/2016

PHILIPS MEDICAL SYSTEMS, NEDERLANDS

Ingenia 1.5t And Ingenia 1.5t S R5.2 K153324 03/22/2016
B.V.

PHILIPS MEDICAL SYSTEMS NETHRLANDS

Multiband Sense K143606 05/08/2015
BV

PHILIPS MEDICAL SYSTEMS, NEDERLAND

O-Mar K143253 04/09/2015
B.V.

PHILIPS MEDICAL SYSTEMS NEDERLANDS

Mdixon Xd K143128 03/20/2015
B.V.

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Page Last Updated: 09/25/2023

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