(36 days)
Not Found
No
The summary describes image analysis, measurement tools, 3D registration, and segmentation based on user input (seed point). There is no mention of AI, ML, deep learning, or any related concepts. The description focuses on traditional image processing and analysis techniques.
No
The device is an image analysis software used to assist radiologists in evaluating and documenting lesions. It does not provide any treatment or therapy.
No
The device is described as an image analysis software application that assists radiologists in the evaluation and documentation of lesions, providing measurement tools and reporting capabilities. It does not independently provide a diagnosis but rather supports the clinician in their diagnostic process.
Yes
The device description explicitly states that LMS-Liver is an "image analysis software application" and describes its functions solely in terms of software operations on CT images. There is no mention of any accompanying hardware components or hardware-specific functionalities.
Based on the provided information, LMS-Liver is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- LMS-Liver analyzes medical images: LMS-Liver operates on CT images, which are generated by a medical imaging device (CT scanner) and represent anatomical structures. It does not directly analyze biological samples.
- The intended use is image analysis: The intended use clearly states that the software is for "evaluating CT images covering the liver area" and assisting in the "evaluation and documentation of lesions." This is consistent with medical image analysis software, not an IVD.
Therefore, LMS-Liver falls under the category of medical image analysis software, which is a type of medical device, but not an IVD.
N/A
Intended Use / Indications for Use
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.
LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.
Product codes
LLZ
Device Description
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver can segment hepatic lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity.
LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
liver area
Indicated Patient Age Range
adult patients
Intended User / Care Setting
radiologists and other clinicians qualified to interpret CT images.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 8 2007
510(k) Summary
Submitter's Information
Submitted by MEDIAN Technologies Le Solaris 120 rue Albert Caquot 06560 Sophia Antipolis France Fax: +33 93 333 777 Contact: Fredrik Brag, CEO Fredrik.brag@mediantechnologies.com Tel: +33 93 333 777
Questions or requests for further information should be addressed to: Michael Auffret, VP Product Management Michael.auffret@mediantechnologies.com Tel: +33 4 92 90 65 84
Date summary was prepared: May 14, 2007
Name of Device
Proprietary name: LMS-Liver Common name: Image visualization and analysis software package Classification Name: Class II 21 CFR 892.2050 LLZ
Predicate Devices
| Manufacturer: | SIEMENS | CEDARA |
|---|---|---|
| Common | ||
| Name: | Accessory to Computed Tomography | |
| X-ray System /II/ 90 | Accessory to Computed Tomography | |
| X-ray System /II/ 90 | ||
| Trade Name: | Syngo TrueD software | Cedara I-Response; Cedara PET/CT |
| 510(k) | ||
| Number: | K061671 | K053301 |
Device Description
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver can segment hepatic lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity.
1
LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.
Indication for use
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.
LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.
Substantial Equivalence Comparison Chart
| Manufacturer | Siemens | Cedara | MEDIAN |
|---|---|---|---|
| Product Name | Syngo | ||
| TrueD | |||
| software | Cedara I- | ||
| Response; | |||
| Cedara | |||
| PET/CT | LMS-Liver | ||
| 510(k) | K061671 | K053301 | |
| Software only solution | √ | √ | √ |
| Windows XP operating system | √ | √ | √ |
| CT scans as Input | √ | √ | √ |
| Support the oncological workflow by | |||
| helping the user assess and document | |||
| morphological changes in therapy | |||
| follow-up examinations | √ | √ | √ |
| Compare medical imaging data from | |||
| different time points | √ | √ | √ |
| Landmark matching and visual | |||
| alignment | √ | √ | √ |
| Lesion comparison over time | √ | √ | √ |
| Report Generator | √ | √ | √ |
2
Safety
A comprehensive hazard analysis was carried out on MEDIAN Technologies' LMS-Liver software. It concluded that residual risks are acceptable when weighed against the intended benefits of the system.
Conclusion
LMS-Liver software does not raise new safety risks and is equivalent in function to existing legally marketed devices. LMS-Liver software is therefore substantially equivalent with respect to safety and effectiveness to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers. The logo appears to be a seal or emblem, possibly representing a government agency or organization related to health and human services in the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Median Technologies % Mr. Chas Burr President Chas Burr Q/R Services, Inc. 11 Mystic Avenue WINCHESTER MA 01890-2920
Re: K071241
Trade/Device Name: LMS-Liver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 30, 2007 Received: May 3, 2007
Dear Mr. Burr:
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.
Image /page/3/Picture/9 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" at the top. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo is circular and contains the letters "FDA" in a stylized design.
4
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). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): _K071241
Device Name: LMS-Liver
Indications for Use:
LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports.
LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images.
LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.
Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Hulut lemer no
(Division Sign-Off) Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number