FDA.reportPublic FDA data

inHEART Models Explorer

Primary DI
03770019599020
Brand
inHEART Models Explorer
Company
INHEART
Model
v2.5.0
Device description
inHEART Models Explorer is a a web-based 3D visualization software that permits display, review, analysis, annotation and export of the cardiac 3D models generated from inHEART MODELS Shaper.inHEART Models Explorer is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
Published
2022-12-12
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220727000inHEART MODELSInheart, Sas2022-05-10LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770019599020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770019599020037700195990203770019599020

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
269837780
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770019599112inHEART Models Explorerv3.0.0NA2025-07-15
03770019599099inHEART MODELS Explorerv2.8.02024-04-08
03770019599037inHEART Models Shaperv1.4.02022-12-12
03770019599006inHEART Models Explorerv2.2.12021-04-06
03770019599013inHEART Models Shaperv1.2.02021-04-06
03770019599075inHEART MODELS AIv1.1.02024-04-09
03770019599082inHEART MODELS Shaperv1.8.02024-04-08

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