AccessGUDID - DEVICE: inHEART Models Shaper (03770019599013)

GUDID

Device Identifier (DI) Information

Brand Name: inHEART Models Shaper
Version or Model: v1.2.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INHEART

Primary DI Number: 03770019599013
Issuing Agency: GS1
Commercial Distribution End Date: December 12, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 269837780 *Terms of Use

Device Description: inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs. inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47502	Image segmentation application software	An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: adbafd25-9981-48e1-8790-25112c5060a3
Public Version Date: June 26, 2024
Public Version Number: 2
DI Record Publish Date: April 06, 2021