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Sign in to claim this brandPhilips Medical Systems GmbH, Dmc
US
Last updated May 23, 2026
What Philips Medical Systems GmbH, Dmc makes
The company manufactures diagnostic X-ray equipment, including stationary X-ray tube housing assemblies, anti-scatter grids, and digital imaging systems. Products include stationary X-ray generators, digital fluoroscopic systems, and computed radiography scanners, as well as digital conversion systems for X-ray imaging. Examples include the EasyDiagnost Eleva, ProGrade, and Certeray iX systems, along with custom OEM anti-scatter grids and rotating anodes for X-ray tubes.
These devices are regulated under FDA classifications, with most falling into Class I or Class II. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. medical device authorisation requirements. The company operates from a U.S. subsidiary of Philips Medical Systems GmbH.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Philips Medical Systems GmbH, Dmc manufacture?
Philips Medical Systems GmbH, Dmc specializes in diagnostic X-ray equipment. Their product lineup includes stationary X-ray tube housing assemblies, anti-scatter grids (used to reduce scattered radiation in imaging), stationary X-ray generators, digital fluoroscopic systems, stationary basic diagnostic X-ray systems, and computed radiography digital imaging scanners. These devices are designed for medical imaging applications where precise and high-quality X-ray visualization is required, such as in radiography and fluoroscopy.
Where is Philips Medical Systems GmbH, Dmc based, and how does that relate to its regulatory standing?
Philips Medical Systems GmbH, Dmc operates through a U.S. subsidiary, meaning its U.S.-based devices are subject to FDA regulations. The company’s devices are listed in the FDA’s 510(k) and UDI registries, which are databases used to track medical devices that have undergone the necessary authorisation processes in the U.S. This reflects compliance with FDA requirements for medical device safety and performance before they can be marketed in the U.S. market.
Which regulatory registries list Philips Medical Systems GmbH, Dmc’s devices, and why?
Philips Medical Systems GmbH, Dmc’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) registry includes devices that have been cleared through the FDA’s premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device. The UDI registry ensures each device has a unique identifier for tracking, improving patient safety and regulatory oversight by providing clear traceability throughout the device’s lifecycle.
How are Philips Medical Systems GmbH, Dmc’s devices classified under FDA regulations?
The devices manufactured by Philips Medical Systems GmbH, Dmc fall under FDA classifications of Class I or Class II. Class I devices generally pose minimal potential risk and are subject to general controls, while Class II devices require additional performance standards to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, risk level, and the potential harm if it malfunctions, ensuring appropriate regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (68)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anti-scatter Grid (40/12/180) - OEM | 9896-010-74431 | FDA UDI | Class I | Active |
| EasyDiagnost Eleva | 9890-010-03632 | FDA UDI | Class II | Active |
| Sro 0950 Rot 350 | 9874-007-01122 | FDA UDI | Class I | Active |
| Portable DR Panel Protector | 9890-010-88161 | FDA UDI | Class II | Unknown |
| Sro 2550 Rot 360 | 9890-000-86091 | FDA UDI | Class I | Active |
| Srm 0511 Rot 501 | 9890-000-03362 | FDA UDI | Class I | Active |
| Anti-scatter Grid (60/10/180) | 9896-010-64302 | FDA UDI | Class I | Active |
| Srm 0511 Rot-Gs 501 | 9890-000-03822 | FDA UDI | Class I | Active |
| ProGrade | 9897-010-01041 | FDA UDI | Class II | Active |
| Mrc 200 0508 Rot 1003 | 9890-000-85132 | FDA UDI | Class I | Active |
| ProxiDiagnost N90 | 706100 | FDA UDI | Class II | Active |
| Certeray iX | 9890-000-65307 | FDA UDI | Class I | Active |
| Mrc 200 0407 Rot-Gs 1004 | 9890-000-86501 | FDA UDI | Class I | Active |
| ProGrade | 9897-010-01041 | FDA UDI | Class II | Active |
| Mrc 200+ 0407 Rot-Gs 1008 | 9890-000-86621 | FDA UDI | Class I | Active |
| Ro 1750 Rot 360 | 9890-000-86111 | FDA UDI | Class I | Active |
| Ct8000 | 9806-058-01212 | FDA UDI | Class I | Active |
| Certeray iX | 9890-000-65306 | FDA UDI | Class I | Active |
| XS-100 X-Ray Tube Assembly | 9806-058-00542 | FDA UDI | Class I | Active |
| DigitalDiagnost | 712226 | FDA UDI | Class II | Active |
| PCR Eleva | 9890-010-83831 | FDA UDI | Class II | Active |
| Anti-scatter Grid (60/10/110) | 9896-010-64282 | FDA UDI | Class I | Active |
| Pcr Eleva | 9890-010-83731 | FDA UDI | Class II | Active |
| XS-100 Generator | 9806-058-00222 | FDA UDI | Class I | Active |
| Anti-scatter Grid (36/12/100) | 9896-010-61302 | FDA UDI | Class I | Active |
| Anti-scatter Grid (40/12/140) - OEM | 9896-010-74421 | FDA UDI | Class I | Active |
| Mrc 200 0508 Rot-Gs 1003 | 9890-000-86521 | FDA UDI | Class I | Active |
| Anti-scatter Grid (40/8/180) - OEM | 9896-010-74401 | FDA UDI | Class I | Active |
| Da200ultra+lmb | 9890-000-87331 | FDA UDI | Class I | Active |
| Grid Landscape for SkyPlate large | 9896-010-74381 | FDA UDI | Class I | Active |
| Precision CRF | 706400 | FDA UDI | Class II | Active |
| Sro 32100 Rot 351 | 9874-094-00362 | FDA UDI | Class I | Active |
| Dr 1833 | 9890-000-86171 | FDA UDI | Class I | Active |
| DigitalDiagnost | 712227 | FDA UDI | Class II | Active |
| Mrc 200+ 0508 Rot-Gs 1003 | 9890-000-86751 | FDA UDI | Class I | Active |
| Mrc 200 0310 Rot-Gs 1004 | 9890-000-85092 | FDA UDI | Class I | Active |
| SkyPlate large | 4598-012-4298. | FDA UDI | Class II | Unknown |
| SkyPlate small | 9897-010-00843 | FDA UDI | Class II | Unknown |
| SkyPlate large | 9897-010-00834 | FDA UDI | Class II | Unknown |
| Mrc 200 0508 Rot 1001 Preowned | 9890-000-30011 | FDA UDI | Class I | Active |
| Dr 1817 | 9890-000-86151 | FDA UDI | Class I | Active |
| Philips Radiology Smart Assistant | 1.0 | FDA UDI | Class II | Unknown |
| Velara R/F 2T | 9890-000-70298 | FDA UDI | Class I | Active |
| XS-100 X-Ray Tube Assembly | 9806-058-00541 | FDA UDI | Class I | Active |
| Ctr1600 | 9890-000-87211 | FDA UDI | Class I | Active |
| Sro 33100 Rot 360 | 9890-000-86101 | FDA UDI | Class I | Active |
| Ro 1750 Rot 380 | 9890-000-86461 | FDA UDI | Class I | Active |
| Ro 3050 Rot 350 | 9874-002-07122 | FDA UDI | Class I | Active |
| Anti-scatter Grid (60/10/140) | 9896-010-64292 | FDA UDI | Class I | Active |
| Sro 33100 Rot 380 | 9890-000-86481 | FDA UDI | Class I | Active |
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