FDA.reportPublic FDA data

VueJect® Ultrasound Enhancing Agent Delivery System

Primary DI
10841716104241
Brand
VueJect® Ultrasound Enhancing Agent Delivery System
Company
ACIST MEDICAL SYSTEMS, INC.
Model
020271
Device description
The VueJect® Ultrasound Enhancing Agent Delivery System is a syringe-based automatic contrast injection system intended for the vascular administration of contrast. ACIST part numbers associated with this device are 801485-001, 895110-001 (VueJect Evaluation Injector), 895109-001 (VueJect Demo Injector), 895102-001 (VueJect Loaner), and 899060-001 (VueJect Exchange). The separate part numbers and associated SKUs for the Demo, Loaner, and Exchange configurations were established for internal inventory and financial controls. Each configuration links through its bill of materials to packaged injector part number 801485-001.
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IZQInjector, Contrast Medium, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZQInjector, Contrast Medium, AutomaticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262115000VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.2026-08-03IZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841716104245PackageGS11In Commercial Distribution
10841716104241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610424530841716104245
1084171610424110841716104241

Regulatory Flags#

DUNS number
926684994
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841716104210VueJect® V90, 90 cm tubing0202412026-11-05
10841716104227VueJect® V150, 150 cm tubing0202422026-11-05
10841716104234VueJect® Remote Dock0202322026-11-05
10841716103657AngioTouch Module (15')0193120193122026-06-08
10841716104296ACIST Pro Diagnostic System0193040193042026-06-07
10841716102704ACIST VeraPro HiFi 1650188042026-05-26
10841716102728ACIST VeraPro FLX 1650188062026-05-26
10841716102742ACIST VeraPro S100 Multi-Use Syringe0188082026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity Syringe0188112026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and Transducer0188142026-05-26
10841716103992ACIST HDi™ Cart0179912026-03-04
10841716103442CT Exprès Bottle Spike A6404582025-12-09
10841716103466CT Exprès Day Set III HP6404602025-12-09
10841716101561BT2000 Automated Manifold Kit0146132020-11-06
10841716101943A2000 Multi-use Syringe Kit0146122018-06-06
10841716101974BT2000 Automated Manifold Kit0146132018-06-06
10841716101998AngioTouch® Kit0146442018-06-06
10841716102001AngioTouch® Kit0146452018-06-06
10841716102155A1000 Single Use Syringe Kit0166062019-10-09
10841716102162Single-use Syringe Kit0166052019-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716104210VueJect® V90, 90 cm tubingACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
10841716104227VueJect® V150, 150 cm tubingACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
10841716104234VueJect® Remote DockACIST MEDICAL SYSTEMS, INC.IZQ2026-11-05
09345390003462MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2026-08-19
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDIZQ2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-12-10
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.IZQ2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.IZQ2025-12-10
10841716103442CT Exprès Bottle Spike AACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
10841716103466CT Exprès Day Set III HPACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
04052536230495ulrichINJECT CT motionUlrich GmbH & Co. KGIZQ2025-12-02
10841716103480CT Exprès Patient SetACIST MEDICAL SYSTEMS, INC.IZQ2025-08-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
49345390003095MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDIZQ2025-03-28
17630039302051Remote ControlBracco Injeneering SAIZQ2024-05-29
04052536166459ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166473ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175130ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175222ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203642ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203673ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203703ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203833ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203857ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166466ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166480ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175147ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29