(35 days)
Not Found
No
The summary describes standard medical image visualization and processing tools, and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details about training and test sets typically associated with AI/ML development.
No
Explanation: The device is a software application for displaying and visualizing medical image data. It states that images can be acquired, stored, communicated, processed, printed, rendered, and displayed. There is no mention of it being used for treatment or therapy. It functions as an image viewing and analysis tool for diagnostic purposes rather than a therapeutic intervention.
No
The device is a software application for the display and 3D visualization of medical image data, providing tools for review and analysis, but it does not claim to diagnose or detect diseases. Its purpose is to present data, not interpret it for diagnostic conclusions.
Yes
The device is explicitly described as a "PC-based software application" and its functions are solely related to the processing, display, and management of medical image data. There is no mention of any accompanying hardware components that are part of the device itself.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lucion's Function: The Lucion™ software application processes and visualizes medical image data (CT, MRI). It does not analyze biological samples.
- Intended Use: The intended use is for the display and 3D visualization of medical image data for review by trained professionals. This is a medical imaging software function, not an in vitro diagnostic function.
Therefore, the Lucion™ software falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
The Lucion™ is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Product codes
LLZ
Device Description
Mevisys Lucion™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MRI scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including physicians, nurses, and technicians.
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
75
FEB | | 7005
Image /page/0/Picture/3 description: The image shows the word "MEViSYS" in a bold, sans-serif font. The letters "MEV" are solid black, while "iSYS" are outlined in black. Below the word, there is some Korean text that reads "(주)메비시스".
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: Oct 25, 2004
Submitter's Information: 21 CFR 807.92(a)(1) Mevisys, Co., Ltd. Alumni Venture Hall, Room 5103 KAIST, 400 Gusongdong Yusonggu Daejon 305-701 Korea
Trade Name, Common Name and Classification: 21 CFR 807.92(a) (2) Lucion™M Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device 1: 21 CFR 807. 92(a) (3)
| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K022692 |
| Device Name | VOXELPLUS PACS |
| Applicant | Mevisys Co.,Ltd. |
| KAIST-AVH 5103, 375-1 Guseong-dong Yuseong-gu | |
| Daejeon 305-701, Korea | |
| Contact | Carl Alletto |
| Product Code | LLZ |
| Date Received | 08/13/2002 |
| Decision Date | 10/11/2002 |
Predicate Device 2:
| Device Classification Name | SYSTEM, X-Ray, Tomography Computed | |
|---|---|---|
| Regulation Number | 892.1750 | |
| 510(k) Number | K020929 | |
| Device Name | SmartScore 3.5, 4.0, 4.5 |
1
Lucion Page 76
Image /page/1/Picture/1 description: The image contains the word "MEViSYS" in a bold, sans-serif font. The letters "MEVi" are solid black, while the "SYS" is outlined in black. Below the word is the text "(주)메비시스" in a smaller font.
| Applicant | GE Medical Systems.
283 Rue De LaMiniere Bp34, Buc Cedex, FR 78533 |
|---------------|-----------------------------------------------------------------------|
| Contact | Carl Alletto |
| Product Code | JAK |
| Date Received | 03/22/2002 |
| Decision Date | 04/03/2002 |
Device Description: 21 CFR 807 92(a) (4)
Mevisys Lucion™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.
Indications for Use: 21 CFR 807 92(a) (5)
medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a) (6)
The device is a software application and 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 Lucion™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. Lucion™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, flowing design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2005
Mevisys Co., Ltd. % Mr. Richard C. Lanzillotto US Agent North American Technical Services Corp. 30 Northport Road SOUND BEACH NY 11789-1734
Re: K050033 Trade/Device Name: Lucion™ Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 5, 2005 Received: January 11, 2005
Dear Mr. Lanizillotto:
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 (Premarket Approval), 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.
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.
3
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the logo for MEVISYS. The word "MEVISYS" is written in a bold, sans-serif font. The first part of the word, "MEVI," is in black, while the "SYS" part is outlined in black. Below the logo, there is some Korean text that appears to be the company's name in Korean.
(Indications for Use Form)
Page 1 of -1
510(k) Number: Kos o
Device Name: Lucion™ by MEViSYS Co. Ltd.
Indications for Use:
The Lucion™ is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Ingram
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(Division Sign-Off) Division of Reproductive, Abdon and Padiological Devices 5 1 (k) Number __