AccessGUDID - DEVICE: PROMAP LITE – 3D PROSTATE SUITE (03665134000714)

GUDID

Device Identifier (DI) Information

Brand Name: PROMAP LITE – 3D PROSTATE SUITE
Version or Model: KSOF-2602
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOELIS

Primary DI Number: 03665134000714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 290318455 *Terms of Use

Device Description: ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure.

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?
47502	Image segmentation application software	An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological
ITX	Transducer, Ultrasonic, Diagnostic
IYO	System, Imaging, Pulsed Echo, Ultrasonic
IYN	System, Imaging, Pulsed Doppler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170521	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: 1e2c0ba0-bafa-4a3e-9083-aba96578ca63
Public Version Date: March 19, 2025
Public Version Number: 2
DI Record Publish Date: July 21, 2022