TOMTEC Imaging Systems GMBH

FDA Device Registration & Listing · UNTERSCHLEISSHEIM Bavaria, DE · Registration 8043836

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
8043836
FEI Number
1000185293
Entity Name
TOMTEC Imaging Systems GMBH
City/State/Country
UNTERSCHLEISSHEIM Bavaria, DE
Establishment Address
Freisinger Strasse 9, UNTERSCHLEISSHEIM Bavaria 85716, DE
Establishment Type(s)
Manufacture Medical Device
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
K201632
PMA Number
N/A

All Registered Proprietary Names

Ultrasound Workspace TomTec-Arena TOMTEC-ARENA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-03-19
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-03-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-03-19
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-12-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-10-19
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2020-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

Ondrea Bermudez Email: Ondrea.Bermudez@philips.com Phone: (443) 3200028

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
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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3012081348 THE SENTINEL IMAGING GROUP, INC Clarks Summit, PA, US
3025786376 ACO HEALTHCARE CO., LTD. Taoyuan City, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043836. Last updated year: 2026. Please use registration number 8043836 when referencing this establishment in official correspondence.
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