Philips Medical Systems DMC GmbH

FDA Device Registration & Listing · HAMBURG, DE · Registration 3003768251

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003768251
FEI Number
3003768251
Entity Name
Philips Medical Systems DMC GmbH
City/State/Country
HAMBURG, DE
Establishment Address
Roentgenstrasse 24, HAMBURG 22335, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K945278
PMA Number
N/A

All Registered Proprietary Names

HF GENERATOR IV 15KW CT XS Generator Velara Certeray IXION III HF GENERATOR Spellman HF generator XS-100 Generator DU, DR CTR22xx Series H.T Converter Tank BV300 Spellman Monoblock XS-100 X-ray tube assembly X-Ray Tube, Brightview XCT SRO (Super Rotalix) CTR17xx Series CTR21xx Series CTxxxx Series Monoblock IXION V RO (Rotalix) SRM (Super Rotalix Metal) MRM (Maximus Rotalix Metal) IXION MONOBLOCK DRxxx Series DAxxx Series vMRC Performance CT XS Tube MRC (Maximus Rotalix Ceramic) DUxxx Series ProxiDiagnost N90 PCR Eleva 1.2 DigitalDiagnost BuckyDiagnost Juno DRF Philips Radiology Smart Assistant MicroDose SI Fuji Ultima EC-MA Cassettes: CC, LC, PC, C-H, D-M, D-S DigitalDiagnost C90 BuckyDiagnost VARIOUS MODELS CENTERING LIGHT (OR LASER) SkyFlow Essenta DR IntelliSpace PACS 4.X IntelliSpace Breast BuckyDiagnost Film and Accessories EasyDiagnost Eleva CombiDiagnost R90 Radiography 7000 M MicroDose SI (model L50) L30 DigitalDiagnost EasyDiagnost DigitalDiagnost, BuckyVision, Bucky Diagnost TH, Bucky Diagnost CS2/CS4 RALCO R302 DigitalDiagnost C90 PCR Eleva S Plus PCR Eleva Corado PCR Eleva S HI Res PCR Eleva S PCR Cosima X Eleva ProxiDiagnost N90 / Precision CRF Optimus, Velara Bucky Diagnost Family

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZO Generator, High-Voltage, X-Ray, Diagnostic Radiology Class 1 892.1700 2006-02-21
ITY Assembly, Tube Housing, X-Ray, Diagnostic Radiology Class 1 892.1760 2006-02-21
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2018-02-13
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2018-02-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2010-01-14
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-05-25
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-05-25
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2021-05-25
IXY Holder, Radiographic Cassette, Wall-Mounted Radiology Class 1 892.1880 2001-05-31
IXL Device, Spot-Film Radiology Class 2 892.1670 2013-04-30
KXJ Table, Radiologic Radiology Class 2 892.1980 2013-04-30
KPW Device, Beam Limiting, X-Ray, Diagnostic Radiology Class 2 892.1610 2013-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-01-07
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-01-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2015-05-26
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2015-05-26
IXA Cassette, Radiographic Film Radiology Class 2 892.1850 2001-06-12
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2019-01-22
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2019-01-22
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-01-22
IXQ Table, Radiographic, Stationary Top Radiology Class 2 892.1980 2006-02-21
IWE Monitor, Patient Position, Light-Beam Radiology Class 1 892.5780 2001-06-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-02-10
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2016-02-10
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2008-10-30
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2008-10-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-08-09
IYB Tube Mount, X-Ray, Diagnostic Radiology Class 1 892.1770 2006-02-21
IXR Table, Radiographic, Tilting Radiology Class 2 892.1980 2007-11-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2007-11-21
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2007-11-21
IXL Device, Spot-Film Radiology Class 2 892.1670 2007-11-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-01-25
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2021-01-25
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-01-25
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2024-02-19
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2013-04-30
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2015-03-12
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2007-11-21
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2007-11-21
IXR Table, Radiographic, Tilting Radiology Class 2 892.1980 2009-04-27
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2007-11-21
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2007-11-21
KPW Device, Beam Limiting, X-Ray, Diagnostic Radiology Class 2 892.1610 2006-04-20
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-10-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-10-05
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2020-10-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2001-05-31
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2024-01-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-01-17
IZO Generator, High-Voltage, X-Ray, Diagnostic Radiology Class 1 892.1700 2001-05-31
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2008-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Pedroza Business: Philips Email: Martin.Pedroza@Philips.com Phone: (440) 2197243

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K950291 Fischer Imaging Corp. DIGITAL 625HF 1995-03-23
K163715 Philips Medical Systems Nederland B.V. Allura Xper R9 2017-01-26
K863853 Superior Medical Products EAZY COVERS 1987-03-06
K953974 Medivision Medical Imaging, Ltd. CAMVISION 1000 1996-09-09
K024012 Ge Oec Medical Systems OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM 2003-03-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2011 Philips Medical Systems North America Co. Phillips 2
The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
Z-0001-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0002-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0003-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Z-0004-2026 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands 2
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003768251. Last updated year: 2026. Please use registration number 3003768251 when referencing this establishment in official correspondence.
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