ACIST MEDICAL SYSTEMS, INC.

FDA Device Registration & Listing · EDEN PRAIRIE, MN, US · Registration 2134243

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
2134243
FEI Number
3001726808
Entity Name
ACIST MEDICAL SYSTEMS, INC.
City/State/Country
EDEN PRAIRIE, MN, US
Establishment Address
7905 FULLER ROAD, EDEN PRAIRIE, MN 55344, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
ACIST MEDICAL SYSTEMS, INC. (Owner Number: 9028115)
Owner / Operator Contact Address
7905 FULLER RD., --, Eden Prairie, MN 55344, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ACIST Rapid Exchange System (RXi)_dPR and Navvus II MicroCatheter EmpowerCTA Injector System (Empower Sync Remote) Rapid Exchange (RXi) System Navvus Catheter ACIST CVi®1 Contrast Delivery System A1000V Syringe Kit VeraPro AngioTouch HiFi 165 VeraPro AngioTouch FLX 165 VeraPro S100 VeraPro S100 LV1 VeraPro AMT ACIST Rapid Exchange System (RXi) and Navvus II MicroCatheter Fastload MR Syringe Pack, EmpowerMR Injector System ACIST HDi® System ACIST Kodama® Intravascular Ultrasound Catheter ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit CVI INJECTION SYSTEM CMS2000 ACIST CVi® BT2000 Manifold Kit ACIST CVi® AngioTouch® Kit AT P65 ACIST CVi® A2000 Syringe Kit ACIST CVi® AngioTouch® Kit AT P54 ACIST CVi® Contrast Delivery System CT Expres 3D Contrast Media Delivery System Day Set III HP Bottle Spike Patient Set AngioTouch Handcontroller Kits (Models ATP54, ATP65, ATR54, ATL65) ACIST RXi Mini System and Accessories ACIST Rapid Exchange (RXi) System with dPR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBI Catheter, Pressure Monitoring, Cardiac Cardiovascular Class 2 870.1200 2024-09-12
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2024-09-12
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2008-07-10
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2008-07-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2008-07-10
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2014-03-10
OBI Catheter, Pressure Monitoring, Cardiac Cardiovascular Class 2 870.1200 2014-03-10
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2019-09-24
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2026-05-14
OBI Catheter, Pressure Monitoring, Cardiac Cardiovascular Class 2 870.1200 2019-12-04
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2008-07-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-10-30
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2017-10-30
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2019-09-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-09-24
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2014-08-04
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2002-01-14
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2018-03-08
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2023-09-25
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2014-08-04
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2017-09-21
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2020-04-20

Official Correspondent

Milana Solganik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACIST MEDICAL SYSTEMS, INC.
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 2134243. Last updated year: 2026. Please use registration number 2134243 when referencing this establishment in official correspondence.
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