Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012044688

FEI Number

3012044688

Entity Name

ACIST EUROPE BV

City/State/Country

Heerlen Limburg, NL

Establishment Address

Argonstraat 3, Heerlen Limburg 6422PH, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ACIST Europe BV (Owner Number: 10084954)

Owner / Operator Contact Address

Argonstraat 3, Heerlen, NL-LI 6422PH, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K932055

PMA Number

N/A

All Registered Proprietary Names

EmpowerCTA+ Injector System Empower CTA Injector System EmpowerMR Injector System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-04-20
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2022-04-20
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-04-20
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2022-04-20
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2022-04-20
FIH	Pump, Infusion Or Syringe, Extra-Luminal	Gastroenterology, Urology	Class 2	876.5820	2022-04-20

Official Correspondent

Emile Schoffelen

US Agent Details

Jonathan Watkins Business: ACIST Medical Systems, Inc. Email: jon.watkins@bracco.com Phone: (651) 8558002

Related Public Records

Same Entity

ACIST Europe BV

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
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
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

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.

Similar Registrations

Registration Number	Establishment Name	Location
2025475	VALHALLA SCIENTIFIC, INC.	Poway, CA, US
3004987887	USCOM LIMITED	SYDNEY New South Wales, AU
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3004782476	Impedimed Limited	Lindfield New South Wales, AU
3007305624	GUANGDONG BIOLIGHT MEDITECH CO., LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012044688. Last updated year: 2026. Please use registration number 3012044688 when referencing this establishment in official correspondence.