Hybrid 3D

Basic Information

• Brand Name: Hybrid 3D
• Primary DI: 00859873006042
• Version / Model: 1.0
• Catalog Number: P54
• Company Name: Hermes Medical Solutions AB
• Labeler DUNS: 354140220
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-05
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 275b3020-e993-4e31-aded-92b017807667
• Distribution End Date: 2022-01-31

Device Description

Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPS	System, Tomography, Computed, Emission	Radiology	892.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40937	Nuclear medicine system workstation	A freestanding, multi-purpose, image processing device that can be a component of one or more nuclear medicine imaging systems, e.g., a gamma camera, PET system or SPECT system. It is sometimes considered to be a component to a picture archiving and communication system (PACS). It does not contain the controls for the direct operation of the diagnostic imaging system. It can receive and transmit data both on-line and off-line and is typically located at a site remote from the operator's console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more nuclear medicine based imaging systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859873006042	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]