(54 days)
No
The document describes a standard PACS system for image management and processing, with no mention of AI, ML, or related concepts.
No.
The device is described as medical imaging software for displaying, editing, reviewing, storing, printing, and distributing images, rather than directly treating or diagnosing medical conditions.
No
Explanation: The Xeron PACS is described as an "image management system" intended to display, edit, review, store, print, and distribute images from imaging devices. It does not perform analysis or interpretation of images to provide a diagnosis, but rather manages and processes the images themselves. Its function is to facilitate the workflow of medical imaging, not to diagnose conditions.
Yes
The device description explicitly states that Xeron PACS consists of five software components and describes its function as an image management system within a PACS environment, which is inherently software-based for handling digital images. There is no mention of any accompanying hardware being part of the device itself.
Based on the provided information, the Xeron PACS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Xeron PACS is for displaying, editing, reviewing, storing, printing, and distributing images acquired from medical imaging devices. This is focused on managing and presenting existing images, not on performing tests on biological samples to diagnose conditions.
- Device Description: The description reinforces that it's an image management system for DICOM medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Xeron PACS operates on medical images, which are a different type of data.
N/A
Intended Use / Indications for Use
The Xeron PACS is a medical imaging software application intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
Product codes
LLZ
Device Description
Xeron PACS is an image management system that allows authorized personnel to acquire, display, edit, review, store, print, and distribute standard Digital Imaging and Communications in Medicine (DICOM) medical images within a Picture Archiving and Communication System (PACS) environment. The Xeron PACS system consists of five software components: XP WebStation, XP RadStation, XP Site Administrator, XP Data Router, XP Server Manager. Xeron PACS supports DICOM network structures which allow for efficient medical image acquisition from any medical modality, including CT, MR, CR, and others. Distribution of images is provided to desktop computer systems, computer systems connected by intranet or internet, hardcopy devices, and Hospital Information Systems (HIS).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Xeron PACS has been demonstrated to perform as intended.
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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510(k) Premarket Notification
Page 1 of 2
510(k) SUMMARY
NOV - 7 2006
General Information
| Submitted by: | XERON Healthcare Corp.
A-206 Hi-Tech Venture Center, 647-26
Deungchon-Dong, Gangseo-Gu
Seoul, Korea
Phone: +82 2 3663 8424
Fax: +82 2 3663 8426 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Douglas Kim
A-206 Hi-Tech Venture Center, 647-26
Deungchon-Dong, Gangseo-Gu
Seoul, Korea
Phone: +82 2 3663 8424
Fax: +82 2 3663 8426
Email: douglas_kim@xeron.co.kr |
| Date Prepared: | September 11, 2006 |
Device Name
| Trade Name: | Xeron PACS |
|---|---|
| Common Name: | Picture Archiving and Communications System |
| Classification Name: | System, Image Processing, Radiological, |
| 21 CFR 892.2050 |
Predicate Device
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| GE Medical Systems | ||
| Information Technologies | GE Centricity PACS | K043415 |
1
Device Description
Xeron PACS is an image management system that allows authorized personnel to acquire, display, edit, review, store, print, and distribute standard Digital Imaging and Communications in Medicine (DICOM) medical images within a Picture Archiving and Communication System (PACS) environment. The Xeron PACS system consists of five software components:
- · XP WebStation
- · XP RadStation
- · XP Site Administrator
- · XP Data Router
- · XP Server Manager
Xeron PACS supports DICOM network structures which allow for efficient medical image acquisition from any medical modality, including CT, MR, CR, and others. Distribution of images is provided to desktop computer systems, computer systems connected by intranet or internet, hardcopy devices, and Hospital Information Systems (HIS).
Intended Use
The Xeron PACS is a medical imaging software application intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
Technological Comparison
Xeron PACS and GE Centricity PACS are software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).
Testing
Xeron PACS has been demonstrated to perform as intended.
Conclusions
Xeron PACS is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three parallel lines that curve and merge together, forming a shape that could be interpreted as a stylized human figure or a flame.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
XERON Healthcare Corp. % Mrs. Melissa Mahall Director, Regulatory Affairs Bio-Reg Associates, Inc. 6304 Belmont Circle, Bldg 2 MOUNT AIRY MD 21771
NOV - 7 2006
Re: K062757
Trade/Device Name: Xeron PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 11, 2006 Received: September 20, 2006
Dear Mrs. Mahall:
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/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a circular border.
Protecting and Promoting Public Health
3
Page 2 -
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/cdrh/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
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
K1062757
Device Name: Xeron PACS
Sponsor Name: XERON Healthcare Corp.
Indications for Use:
The Xeron PACS is a medical imaging software application intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
Prescription Use XI (21 CFR 801 Subpart D)
Or
Over-The-Counter Use | | (21 CFR 807 Subpart C)
Do Not Write Below This Line – Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices