AccessGUDID - DEVICE: Standard Imaging StructSure Software (00866562000281)

GUDID

Device Identifier (DI) Information

Brand Name: Standard Imaging StructSure Software
Version or Model: 91340
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91340
Company Name: STANDARD IMAGING INC.

Primary DI Number: 00866562000281
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788084705 *Terms of Use

Device Description: Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.

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?
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHO	Instrument, Quality-Assurance, Radiologic

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: 871c9969-1063-4adb-8854-8657d6010828
Public Version Date: June 30, 2023
Public Version Number: 1
DI Record Publish Date: June 22, 2023