Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012631246

FEI Number

3012631246

Entity Name

MEDPHOTON GMBH

City/State/Country

Salzburg, AT

Establishment Address

Karolingerstrasse 16, Salzburg 5020, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

medPhoton GmbH (Owner Number: 10054933)

Owner / Operator Contact Address

Karolingerstrasse 16, Salzburg, AT-5 5020, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203281

PMA Number

N/A

All Registered Proprietary Names

ImagingRing m Loop-X ImagingRing System Mobile ImagingRing System Loop-X Mobile Imaging Robot IRm ImagingRing m Loop-X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-05-20
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2017-05-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Peter Hasslacher Email: newyork@wko.at Phone: (212) 4215250

Related Public Records

Same Entity

medPhoton GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163715	Philips Medical Systems Nederland B.V.	Allura Xper R9	2017-01-26
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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;
Z-0005-2026	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands	2	Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Similar Registrations

Registration Number	Establishment Name	Location
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012631246. Last updated year: 2026. Please use registration number 3012631246 when referencing this establishment in official correspondence.