FDA 510(k) Applications Submitted by Jan van de Kerkhof
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K143128 |
10/30/2014 |
mDIXON XD |
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. |
| K183063 |
11/05/2018 |
Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland B.V. |
| K193215 |
11/21/2019 |
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland BV |
| K143606 |
12/19/2014 |
MultiBand SENSE |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
| K173356 |
10/25/2017 |
Ingenia Elition S and Ingenia Elition X R5.4 |
Philips Medical Systems Nederland B.V. |
| K173451 |
11/06/2017 |
Ingenia Elition S and Ingenia Elition X |
Philips Medical Systems Nederland B.V. |
| K190461 |
02/26/2019 |
Achieva 1.5T, 3.0T and Intera 1.5T MR Systems |
Philips Medical Systems Nederland B.V. |
| K181479 |
06/05/2018 |
Ingenia Ambition S and Ingenia Ambition X |
Philips Medical Systems Nederland B.V. |
| K212673 |
08/24/2021 |
MR 5300 |
Philips Medical Systems Nederland B.V. |
| K172920 |
09/25/2017 |
3D APT |
Philips Medical Systems Nederland B.V. |
| K162940 |
10/21/2016 |
MultiBand SENSE |
Philips Medical Systems Nederland B.V. |
| K213516 |
11/03/2021 |
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei |
Philips Medical Systems Nederland, B.V. |
| K213583 |
11/12/2021 |
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems |
Philips Medical Systems Nederland B.V. |
| K143253 |
11/13/2014 |
O-MAR |
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
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