AccessGUDID - DEVICE: Hybrid Viewer (00859873006189)

GUDID

Device Identifier (DI) Information

Brand Name: Hybrid Viewer
Version or Model: 7.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P31
Company Name: Hermes Medical Solutions AB

Primary DI Number: 00859873006189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 354140220 *Terms of Use

Device Description: Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPS	System, Tomography, Computed, Emission

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 2aafdb7f-972f-41c5-9112-25f6684991bb
Public Version Date: December 18, 2024
Public Version Number: 1
DI Record Publish Date: December 10, 2024