FDA.reportPublic FDA data

ACIST HDi® Linear Translation System (LTS)

Primary DI
10841716101165
Brand
ACIST HDi® Linear Translation System (LTS)
Company
ACIST MEDICAL SYSTEMS, INC.
Model
017988
Device description
HDi LTS, p/n 701457-003
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841716101169PackageGS11Not in Commercial Distribution
10841716101165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084171610116930841716101169
1084171610116510841716101165

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Regulatory Flags#

DUNS number
926684994
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10841716102520A1000V Single Use Syringe Kit0166052024-05-28
10841716102544A2000 Multi-use Syringe Kit0146122020-11-06
10841716102605A1000 Single Use Syringe Kit0166062020-11-06
10841716102612Single-use Syringe Kit0166052020-11-06
10841716101875ACIST CVi® Contrast Delivery System Injector Head0162242018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
00884838112988Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2026-01-08
04056869957708AcuNav CRYSTAL G Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-11-21
05415067053190ViewFlex™IRVINE BIOMEDICAL, INC.OBJ2025-11-21
00845225003319Visions PV .014P RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
00845225003371Eagle Eye Platinum ST RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
10841716103602ACIST Kodama® Coronary Imaging CatheterACIST MEDICAL SYSTEMS, INC.OBJ2025-08-14
10846835026559NUVISION NAV Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
10846835026566NUVISION Ultrasound CatheterBiosense Webster IncOBJ2025-07-02
00884838126893EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126909Affiniti CVx Diagnostic Ultrasound System Philips Ultrasound LLCOBJ2025-06-23
00884838126923EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126930EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound LLCOBJ2025-06-23
00884838126947Affiniti CVx Diagnostic Ultrasound System Circular EditionPhilips Ultrasound LLCOBJ2025-06-23
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399239NES Reprocessed .035 Stryker CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-21
00850044399178NES Reprocessed Visions PV .018 Digital IVUS CatheterNORTH EAST SCIENTIFIC INCOBJ2025-05-19
00845225012854ICE PIMPhilips Image Guided Therapy CorporationOBJ2025-03-24
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664102Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664091Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
57613327664107Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
04056869281483AcuNav Crystal Ultrasound CatheterSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2025-01-03