(89 days)
Not Found
No
The document describes a system for managing, viewing, and processing medical imaging data, but it does not mention any AI or ML capabilities. The focus is on data handling, workflow management, and basic image processing.
No.
The device is described as a solution for managing, viewing, and archiving imaging data, not for treating any medical condition or directly affecting the body.
No
Imagys is a solution for the management, viewing, processing, and archiving of imaging data, and explicitly states that it is the user's responsibility to ensure conditions are "consistent with a clinical diagnostic use of the data," implying the device itself does not perform diagnostics.
Yes
The device is described as a "computing and software solution" and runs on "any standard PC and servers". While it interacts with imaging devices, the core device being submitted for 510(k) appears to be the software itself, not the hardware it runs on or the imaging modalities it processes data from.
Based on the provided text, Imagys is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Imagys's Intended Use: The intended use of Imagys is focused on the management, viewing, processing, and storage of medical imaging data acquired from various imaging modalities (CT, MR, etc.). It deals with images of the body, not with analyzing biological specimens.
- No Mention of Specimen Analysis: The description of Imagys does not mention any functionality related to the analysis of biological samples or specimens.
Therefore, Imagys falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) related solution, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the O management, the viewing, the printing, the printing, the storage and archiving of imaging data, and the O related documentations, acquired from a variety of imaging devices. Imaging dual, and the U of the inaging parts of a clinical trial workflow including steps : quality control, data processing C and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical ( end users are trained medical professionals and clinical trial actors.D 0
The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed O Radiography), NM (Nuclear Medecine), PET (Positon Emission Roomano), SC (Secondary Capture), US D (Ultrasound), XA (Anglographic), video and more DICOM, or others imaging standards, data accepted by the D Imagys solution.D
D
It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and O the interpretation monitor specifications are consistent with a dinical to the data. This device is I not indicated for mammography use. Lossy compressed mammography-images and digitized films area. O images must not be used for primary image interpretations. Mammography images may only handed on a using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical O specifications approved by the FDA.
Product codes
LLZ
Device Description
Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals and clinical trial actors.
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
Imagys is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process.
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).
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Image /page/0/Picture/0 description: The image contains the logo for Keosys Medical Imaging. The logo consists of a black circle with a white "K" inside, followed by the word "KEOSYS" in black, block letters. Below "KEOSYS" is the phrase "MEDICAL IMAGING" in smaller, black letters.
OCT 12 2010
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification for Imagys in conformance with 21 CFR 807.92.
| Date Prepared: | July 2010. |
|---|---|
| Submitter: | Keosys S.A.S. |
| 1, impasse Augustin Fresnel, Z.A. du Moulin Neuf, B.P. 227 | |
| 44815 Saint-Herblain cedex, FRANCE | |
| Contact name: | Mr. Anthony MOTTIER |
| Contact Email: | anthony.mottier@keosys.com |
| Contact Telephone: | 00 33 (0)2 40 92 26 13 |
| Contact Fax: | 00 33 (0)2 40 92 26 26 |
| Device Trade Name: | Imagys |
| Device Common Name: | Picture Archiving and Communication System |
| Device Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | 21 CFR §892.2050 |
| Product code: | LLZ |
| Device Classification: | Class II |
| Predicate Devices: |
| Name | Manufacturer | 510(k) number |
|---|---|---|
| INTEGRADWeb MPR/MIP | Dynamic Imaging, Inc. | K042313 |
| eFilm Worksattion with Modules | eFilm Medical Inc. | K020995 |
| Visio+ CD Viewer | Keosys S.A.S. | K070606 |
Device Description:
Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.
Indications for Use:
Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors.
The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution.
It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.
This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Testing:
Imagys is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process.
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, formed by three overlapping profiles of human faces.
MAR 16 2011
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Anthony Mottier Quality System Manager Keosys S.A.S. I, ImpasseAugustin Fresnel, Z.A. du Moulin Neuf, B.P. 227 Saint-Herblsin, 44815 FRANCE
Re: K102000
Trade/Device Name: Imagys Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 12, 2010 Received: July 15, 2010
Dear Mr. Mottier:
This letter corrects our substantially equivalent letter of October 12, 2010.
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 (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 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
2
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely Yours,
Mary S Patil
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name: Imagys
Indications For Use:
lmagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the O management, the viewing, the printing, the printing, the storage and archiving of imaging data, and the O related documentations, acquired from a variety of imaging devices. Imaging dual, and the U of the inaging parts of a clinical trial workflow including steps : quality control, data processing C and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical ( end users are trained medical professionals and clinical trial actors.D 0
The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed O Radiography), NM (Nuclear Medecine), PET (Positon Emission Roomano), SC (Secondary Capture), US D (Ultrasound), XA (Anglographic), video and more DICOM, or others imaging standards, data accepted by the D Imagys solution.D
D
It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and O the interpretation monitor specifications are consistent with a dinical to the data. This device is I not indicated for mammography use. Lossy compressed mammography-images and digitized films area. O images must not be used for primary image interpretations. Mammography images may only handed on a using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical O specifications approved by the FDA.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, @fficeref-Beviews Concertion (CDFL) ○エレ
(Division Sign-Off)
510K
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
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