FDA.reportPublic FDA data

EmpowerCTA+ Injector System

Primary DI
47630039302014
Brand
EmpowerCTA+ Injector System
Company
Bracco Injeneering SA
Model
017285, 019775
Device description
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Published
2023-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance
IZQInjector, Contrast Medium, Automatic
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2
IZQInjector, Contrast Medium, AutomaticCardiovascular2
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071378000MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESE-Z-Em, Inc.2007-06-13JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
47630039302014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4763003930201447630039302014

GMDN Terms#

Term, Definition table
TermDefinition
CT contrast medium injection system, line-powered, stationaryAn assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482489007
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17630039302051Remote Control1024092024-05-29
37630039302048Remote Control1024092024-05-29
37630039300495EmpowerSync® Cables0173550173552016-09-20
47630039300812EmpowerCTA®+ Injector System with EDA0173830173832017-10-26
17630039300392Injector head 0173770173772016-09-20
17630039300477Remote Control1024091024092016-09-20
17630039300743Injector1024101024102016-09-20
17630039300767Remote Control (Onyx)1024091024092016-09-20
17630039300798Injector1024101024102017-10-26
17630039300910Injector Head1024102021-03-05
17630039300989Remote Control1024091024092020-05-04
17630039301047Injector head1024102020-05-04
17630039301962Injector Head1024102024-04-26
17630039302037Injector Head1024102024-04-26
17630039301627FastLoad™ MR Syringe Pack 0173480173482024-04-08
17630039300385Hydraulic Controller0173780173782016-09-20
17630039300781Remote Control0173800173802016-09-20
17630039301726EDA Module Kit0173542020-05-05
47630039301000EmpowerCTA®+ Injector System0172852020-05-04
47630039300447EmpowerCTA®+ Injector System with EDA0173830173832016-09-20

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Primary DI, Brand, Company table
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