AccessGUDID - DEVICE: 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE (04987670102370)

GUDID

Device Identifier (DI) Information

Brand Name: 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
Version or Model: USWP-100A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CANON MEDICAL SYSTEMS CORPORATION

Primary DI Number: 04987670102370
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 690575113 *Terms of Use

Device Description: 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE

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):	No
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?
40936	Ultrasound imaging system workstation	A freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, image processing, radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082684	000

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: 18d6d39c-357d-4f14-82e6-295e936aa80e
Public Version Date: November 06, 2019
Public Version Number: 5
DI Record Publish Date: September 01, 2016