AccessGUDID - DEVICE: Standard Imaging PIPSpro Software (00866562000236)

GUDID

Device Identifier (DI) Information

Brand Name: Standard Imaging PIPSpro Software
Version or Model: v5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91309
Company Name: STANDARD IMAGING INC.

Primary DI Number: 00866562000236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788084705 *Terms of Use

Device Description: Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.

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?
40887	Radiation therapy software	An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical
IXG	Phantom, Anthropomorphic, Radiographic
LHO	Instrument, Quality-Assurance, Radiologic
LLZ	System, Image Processing, Radiological
LMB	Device, Digital Image Storage, Radiological
LMD	System, Digital Image Communications, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042733	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: 186d9f3b-ac9e-4f27-a9e2-131c5d4c8a32
Public Version Date: June 16, 2023
Public Version Number: 4
DI Record Publish Date: October 11, 2016