Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013035022

FEI Number

3013035022

Entity Name

ISYS Medizintechnik GmbH

City/State/Country

Kitzbuehel Salzburg, AT

Establishment Address

Bergwerksweg 21, Kitzbuehel Salzburg 6370, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ISYS Medizintechnik GmbH (Owner Number: 10052093)

Owner / Operator Contact Address

Bergwerksweg 21, Kitzbuehel, AT-5 6370, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203720

PMA Number

N/A

All Registered Proprietary Names

IFix Micromate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2016-06-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan Toupin Business: Dawa Medical Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

ISYS Medizintechnik GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013847349	iSYS Medizintechnik GmbH	Untermeitingen Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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3027592416	VIPER EMERGENCY MEDICAL RESTRAINTS, LLC	Shrewsbury, MA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013035022. Last updated year: 2026. Please use registration number 3013035022 when referencing this establishment in official correspondence.