(44 days)
Not Found
No
The description focuses on image visualization, navigation, and processing features typical of a CT colonography workstation, without mentioning AI/ML algorithms for analysis or diagnosis. The "Mentions AI, DNN, or ML" section is explicitly "Not Found".
No
The device is a software-based workstation for displaying and visualizing medical image data of the colon for diagnostic purposes, not for treating any condition.
No
The device is described as a software-based system for the display and visualization of medical image data. It explicitly states that "Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." Therefore, it serves as a tool for facilitating diagnosis by healthcare professionals rather than performing the diagnosis itself.
No
The device description explicitly states it is a "workstation" and utilizes "PC hardware," indicating it is not solely software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- XELIS Function: XELIS is a software device that processes and displays medical images (specifically CT scans of the colon). It does not analyze biological samples or perform any tests on bodily fluids or tissues. Its purpose is to assist radiologists and clinicians in reviewing and interpreting existing medical images.
- Intended Use: The intended use clearly states that the software is for the "display and visualization of 3D and 2D medical image data of the colon." It explicitly says that "Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." This further reinforces that it's a tool for image review, not a diagnostic test itself.
Therefore, XELIS falls under the category of medical image processing and display software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
XELIS™ is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis.
Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians, and referring Physicians as an adjunctive to standard radiology practices for diagnosis.
Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.
Product codes
LLZ
Device Description
XELIS is a CT colonography dedicated workstation designed to help radiologists to examine images. XELIS receives DICOM compliant CT images from a remote PACS server. Both primary 2D and primary 3D review modes are supported to meet the various needs of users.
- Real-time and one-pass navigation based on an unfolded view to show . complex inner wall of colon.
l - . Automatic centerline extraction combining with easy selection UI to help fast path setup.
- . Tagged-stool overlay on endoluminal and band view to enable to handle CT images with minimal preparations.
- . Batch capture for reconstructed images related to lesions during the exam to report and send to clinicians.
Mentions image processing
system, image processing, radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Clinicians, and referring Physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 11, 2008 .
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Tristan Choi, Program Manager INFINITT Co., Ltd. 12F Daerung Post Tower III, 182-4 Guro-dong, Guro-gu, Seoul, 152-050. Korea Tel: +82-2-2194-6673 Fax: +82-2-2194-1698
NOV 20 2008
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | XELISTM |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Device Classification: | 892.2050 |
Predicate Device: 21 CFR 807. 92(a)(3)
| K041761 | K052545 | |
|---|---|---|
| Device Classification | ||
| Name | system, image processing, radiological | system, image processing, radiological |
| Device Name | RAPIDIACOLON | INFINITT G3 PACS |
| Applicant | INFINITT CO., LTD. | INFINITT CO., LTD. |
| Regulation Number | 892.2050 | 892.2050 |
| Classification Product | ||
| Code | LLZ | LLZ |
| Decision Date | 07/13/2004 | 11/08/2005 |
| Classification Advisory | ||
| Committee | Radiology | Radiology |
Device Description: 21 CFR 807 92(a)(4)
XELIS is a CT colonography dedicated workstation designed to help radiologists to examine images. XELIS receives DICOM compliant CT images from a remote PACS server. Both primary 2D and primary 3D review modes are supported to meet the various needs of users.
- Real-time and one-pass navigation based on an unfolded view to show . complex inner wall of colon.
l
1
- . Automatic centerline extraction combining with easy selection UI to help fast path setup.
- . Tagged-stool overlay on endoluminal and band view to enable to handle CT images with minimal preparations.
- . Batch capture for reconstructed images related to lesions during the exam to report and send to clinicians.
Indications for Use: 21 CFR 807 92(a)(5)
XELIS™ is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis.
Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.
Technological Characteristics: 21 CFR 807 92(a)(6)
XELIS™ is a software device that does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for XELIS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2008
INFINITT Co. Ltd % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingston Road NORTHBROOK IL 60062-2096
Re: K082990
Trade/Device Name: XELISTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 4, 2008 Received: November 6, 2008
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
loque In Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Medical
imagination
Indications for Use
510(k) Number (if known): Kog2990 Device Name: XELIS™
Indications for Use:
XELISTA is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis.
Analysis of images and diagnosis is not performed by the software but by Radiologists. Clinicians, and referring Physicians as an adjunctive to standard radiology practices for diagnosis.
Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K0 82990 |
|---|---|
| --------------- | ---------- |