IMAGYS

K102000 · Keosys Sas · LLZ · Oct 12, 2010 · Radiology

Device Facts

• Record ID: K102000
• Device Name: IMAGYS
• Applicant: Keosys Sas
• Product Code: LLZ · Radiology
• Decision Date: Oct 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Imagys is a software-based Picture Archiving and Communication System (PACS) designed for clinical trial workflows. It ingests medical imaging data (DICOM and other standards) from various modalities including CT, MR, CR, NM, PET, US, and XA. The system facilitates secure transfer, quality control, data processing, audit trails, storage, and archiving. It operates on standard PCs and servers. Medical professionals and clinical trial personnel use the software to view and review images for clinical trial management. The device provides tools for data management and visualization, assisting clinicians in assessing imaging data within the context of clinical trials. It does not perform automated diagnostic interpretation but supports the workflow of imaging data management. The system is not intended for mammography interpretation.

Clinical Evidence

Bench testing only. The device underwent performance and functional testing as part of the software development process, documented in a Software Test Plan.

Technological Characteristics

Software-based PACS running on standard PCs and servers. Supports DICOM and other imaging standards. Connectivity via network for data transfer. No specific hardware materials or energy sources defined beyond standard computing infrastructure. Software-based image processing and management.

Indications for Use

Indicated for trained medical professionals and clinical trial actors for the management, viewing, and archiving of medical imaging data (CT, MR, CR, NM, PET, SC, US, XA, video) in clinical trial workflows. Not indicated for mammography use; lossy compressed mammography images and digitized film screen images are contraindicated for primary interpretation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• INTEGRADWeb MPR/MIP (K042313)
• eFilm Worksattion with Modules (K020995)
• Visio+ CD Viewer (K070606)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

K102000

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: | [e-mail] |
| 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 [phone] or [phone] 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

{3}------------------------------------------------

## 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

3

ij