Company ยท DE
Philips Medical Systems Gmbh, DMC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2024. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
45recalls (0 in 12 months)
45recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2024 | K233662 | Radiography 7300 C Philips Medical Systems Dmc GmbH, DE | KPR |
| Feb 14, 2024 | K233678 | Radiography 7000 M Philips Medical Systems Dmc GmbH, DE | IZL |
| Jan 11, 2024 | K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) Philips Medical Systems Dmc GmbH, DE | JAA |
| Oct 19, 2023 | K232910 | CombiDiagnost R90 Philips Medical Systems Dmc GmbH, DE | JAA |
| Dec 13, 2021 | K212186 | Philips Radiology Smart Assistant Philips Medical Systems Dmc GmbH, DE | KPR |
| Sep 21, 2021 | K212837 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, DE | JAA |
| Apr 2, 2021 | K210692 | DigitalDiagnost Philips Medical Systems Dmc GmbH, DE | KPR |
| Dec 3, 2020 | K203087 | CombiDiagnost R90 Philips Medical Systems Dmc GmbH, DE | JAA |
| Sep 30, 2020 | K202564 | DigitalDiagnost C90 Philips Medical Systems Dmc GmbH, DE | MQB |
| Jan 11, 2019 | K182973 | DigitalDiagnost C90 Philips Medical Systems Dmc GmbH, DE | MQB |
| Feb 5, 2018 | K173433 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, DE | OWB |
| Jul 7, 2017 | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems Philips Medical Systems Dmc GmbH, DE | MQB |
| Feb 9, 2017 | K170113 | pixium 4343RCE Philips Medical Systems Dmc GmbH, DE | MQB |
| Jan 31, 2017 | K163210 | Philips CombiDiagnost R90 Philips Medical Systems Dmc GmbH, DE | JAA |
| Dec 22, 2015 | K153318 | Philips Eleva Workspot with SkyFlow Philips Medical Systems Dmc GmbH, DE | MQB |
| Jul 25, 2014 | K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, DE | MQB |
| Apr 25, 2014 | K140771 | PHILIPS ELEVA WORKSPOT Philips Medical Systems Dmc GmbH, DE | MQB |
| Oct 7, 2013 | K131483 | PHILIPS PIXIUM 4343RC Philips Medical Systems Dmc GmbH | MQB |
| Mar 9, 2007 | K070528 | PHILIPS ESSENTA DR Philips Medical Systems GmbH, Dmc | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Philips Medical Systems DMC GmbH Radiography 7300 C;
Model Number: 712037; Open, Classified |
KPR | K233662 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER;
Model Number: (1) 712034, (2) 712035; Open, Classified |
MQB | K202564 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 (1) High Performance, (2) Flex/Value;
Model Number: (1) 712031, (2) 712032; Open, Classified |
KPR | K210692 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH Precision CRF;
Model Number: 706400; Open, Classified |
JAA | K233945 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH CombiDiagnost R90;
Model Number: 709031; Open, Classified |
JAA | K232910 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH ProxiDiagnost N90;
Model Number: 706110; Open, Classified |
JAA | K233945 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 High Performance. radiography and fluoroscopy system Open, Classified |
KPR | K210692 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system Open, Classified |
KPR | K202564 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 High Performance. radiography and fluoroscopy system Open, Classified |
KPR | K202564 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system Open, Classified |
KPR | K210692 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH ProxiDiagnost N90. radiography and fluoroscopy system Open, Classified |
JAA | K212837 |
| Jul 22, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost R90
Software Version R1.0 and R1.1 Open, Classified |
JAA | K203087 |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | K163210 |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | K163210 |
| Nov 7, 2018 | Philips Medical Systems Gmbh, DMC Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030
Stationary Fluoroscopic X-ray System Terminated |
JAA | K163210 |
| Sep 19, 2018 | Philips Medical Systems Gmbh, DMC Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System
Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228. Terminated |
MQB | K141736 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Upgrades (Stitching Patient Support) 712083 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Single Detector (Stitching Patient Support) 712020 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3 (Stitching Patient Support) 712025 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 High Performance
(Stitching Patient Support) 712031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 (Stitching Patient Support) 712225 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC CombiDiagnost R90 (Stitching Patient Support) 709030 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3 (Stitching Patient Support) 712025 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Flex / Value
(Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 Terminated |
MQB | K090625 |
| Mar 23, 2012 | Philips Medical Systems Gmbh, DMC Philips Easy Diagnost Eleva DRF, Software release 4.0
Fluoroscopic image-intensified Stationary X-Ray System. Terminated |
JAA | K031535 |