(302 days)
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No
The document describes a standard DICOM workstation for viewing and managing medical images, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
Zenis is a workstation for viewing and managing medical images, not for therapy delivery.
Yes
The intended use statement explicitly states that "Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments."
Yes
The device description explicitly states "This software-based product" and details its functions related to image and data management on a PC platform, without mentioning any proprietary hardware components. While it relies on commercial PC hardware, the medical device itself is the 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Zenis's function: Zenis is a software platform for viewing, managing, and processing medical images acquired from a Fluoroscopic X-ray system. It works with images of the body, not samples taken from the body.
- Intended Use: The intended use clearly states it's for viewing and analyzing images from an X-ray system.
- Device Description: The description reinforces that it's a PC-based DICOM workstation for medical imaging.
Therefore, Zenis falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Zenis is a PC-based DICOM workstation platform which provides scalable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.
Zenis may be combined with a PACS network or connected directly to a modality through the use of DICOM networking.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Fluoroscopic X-ray system
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Radiology or other departments, clinical review workstation throughout the healthcare facility
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The result of performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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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Exhibit 5 510(k) Summary
AUG 26 2011
Picture archiving and communications system / Model: Zenis
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- Company and Correspondent making the submission
- 1.1 Submitter and US Official Correspondent
Submitter: GENORAY Co., Ltd. Address: #512, Byucksan Technopia, 434-6, Sangdaewon 1-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-716 Korea Telephone No.: +82-31-740-4100 Fax: +82-31-737-8025
- 1.2 Official Correspondent (U.S): Jae Kim Business Manager Correspondent: GENORAY America Inc. 1073 N. Batavia St. Orange, CA 92867, USA Address: Telephone No.: 714-289-8020 Fax: 714-453-9661 Email: jae@genoray.com
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- Establishment Registration Number 3005843418
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- Device Information
| Proprietary/Trade Name: | Picture archiving and communications system
/ Model: Zenis |
|-------------------------|---------------------------------------------------------------|
| Common/Usual Name: | Picture archiving and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Device Class: | Class II per regulation 21 CFR 892.2050 |
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- Equivalent Legally Marketed Device
| Manufacturer: | GE Medical Systems Information Technologies |
|---|---|
| Device Name: | RA600 |
| 510(k) Number: | K042525 (Decision Date - October 1, 2004) |
| Classification: | System, Image Processing, Radiological: LLZ, |
| Class II per regulation 21 CFR 892.2050 |
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5. Description of the Device
Zenis is a PC-based DICOM workstation platform which provides scalable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.
Zenis may be combined with a PACS network or connected directly to a modality through the use of DICOM networking.
6. Indications for use
Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
7. Safety and Effectiveness, comparison to Predicate
Zenis, which is made by GENORAY Co., Ltd., is substantially equivalent to RA600 of GE healthcare. We selected the RA600 as the predicate device already FDA approved. Because of RA600 and Zenis are almost same in function & characteristic. Zenis & RA600 are intended for use as PACS software used for viewing of medical images acquired from modality when installed on suitable commercial-standard PC hardware. The result of performance test and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
Conclusion 8.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 GENORAY Co., Ltd., concludes that the Picture archiving and communications system (Model: Zenis) is safe and effective and substantially equivalent to the predicate device as described above.
GENORAY Co., Ltd.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Genoray Co., Ltd. % Mr. Jae Kim Business Development Manager Genoray America, Inc. 1073 N. Batavia St. ORANGE CA 92867
ANG 2 5 2011
Re: K103181
Trade/Device Name: Picture archiving and communications system (Models: Zenis) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 15, 2010 Received: July 8, 2011
Dear Mr. Kim:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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, perroits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 miber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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
Enclosure
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Indications for use Exhibit 4
510(k) number (if known): `K|0318|
· Device Name: Picture archiving and communications system (Models: Zenis)
Indications for Use:
Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103181
CONFIDENTIAL