Bracco Injeneering S.A.

FDA Device Registration & Listing · LAUSANNE Vaud, CH · Registration 3004753774

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
3004753774
FEI Number
3004753774
Entity Name
Bracco Injeneering S.A.
City/State/Country
LAUSANNE Vaud, CH
Establishment Address
AVENUE DE SEVELIN 46, LAUSANNE Vaud 1004, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bracco Injeneering (Owner Number: 9066379)
Owner / Operator Contact Address
7905 FULLER ROAD, Eden Prairie, MN 55344, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K011160
PMA Number
N/A

All Registered Proprietary Names

EmpowerCTA+ Injector System FastLoad¿ CTA dual Syringe Pack FastLoad¿ CTA dual Syringe Pack with spikes FastLoad¿ CT Syringe Pack FastLoad¿ CT Syringe Pack with spike

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2015-02-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2015-02-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-02-06
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2015-02-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-02-06
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2014-04-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2015-02-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2015-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Bracco Injeneering
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004753774. Last updated year: 2026. Please use registration number 3004753774 when referencing this establishment in official correspondence.
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