FDA.reportPublic FDA data

cvi42

Primary DI
00882916000028
Brand
cvi42
Company
Circle Cardiovascular Imaging Inc
Model
6.x
Published
2024-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082628000
K111373000
K141480000
K213998000
K232661000
K241038000
K242781000
K251027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082628000CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23Circle Cardiovascular Imaging, Inc.2008-11-20LLZ
K111373000CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARECircle Cardiovascular Imaging, Inc.2011-08-23LLZ
K141480000CVI42Circle Cardiovascular Imaging, Inc.2014-08-22LLZ
K213998000cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.2022-07-28QIH
K232661000Myocardial Strain Software ApplicationCircle Cardiovascular Imaging2023-12-07LLZ
K241038000Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging2024-06-07QIH
K242781000cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.2024-10-15QIH
K251027000cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.2025-10-27QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00882916000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00882916000028008829160000288829160000280882916000028

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248028578
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00882916000530TruPlan3.x2023-01-23
00882916001025StrokeSENS LVOv2.x2025-02-05
00882916000523TruPlan2.12022-10-20
00882916000516TruPlan1.xv1.x and v2.02021-03-01
00882916000004cvi425.62017-07-28
00882916000011cvi425.x2019-05-06
00088291600001cvi425.62017-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10