Device
It is used by oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluatio...
Manufacturer
Manteia Technologies Co.,Ltd.
Manteia Technologies Co.,Ltd.
Model: 4.0
DI: 06973127400098
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
It is used by oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. The product has two image processing functions:
(1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck,
thorax, abdomen and pelvis (for both male and female) areas,
(2) Automatic registration: rigid and deformable registration, and
(3) Manual contouring
It also has the following general functions:
Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
Patient management;
Review tool of processed images;
Extension tool;
Plan evaluation and plan comparison;
Dose analysis.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1960d38f-6037-4e52-89a1-6deea67b26bf
Distribution Status:
In Commercial Distribution
DUNS Number:
416535464
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06973127400098
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57812
Name: Radiology DICOM image processing application software
Definition:
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
FDA Product Codes
QKB
Radiological Image Processing Software For Radiation Therapy
Premarket Submissions
Submission Number:
K251351
Supplement Number:
000