(25 days)
No
The description focuses on standard image processing, archiving, and display functionalities common in medical imaging workstations and does not mention AI or ML.
No
This device is a software workstation that processes, displays, and archives diagnostic images. It aids in diagnosis rather than directly treating a condition.
No
The device is a workstation software used for processing and reviewing images, not for acquiring or interpreting diagnostic information directly. Its functions are described as displaying, processing, archiving, and communicating data acquired by other diagnostic imaging devices (Emission Tomography cameras).
No
The device description explicitly states it is a "computer workstation software" that "runs on Microsoft Windows XP based PC workstation (high resolution color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software." It also mentions optional hardware like DVD and optical disk archive devices. This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device processes and displays images acquired directly from a patient using Emission Tomography cameras. It's dealing with in-vivo imaging data, not in-vitro specimens.
- The intended use clearly states "display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology". This aligns with medical imaging processing, not laboratory testing of specimens.
Therefore, the XELERIS 2 PROCESSING AND REVIEW WORKSTATION is a medical imaging processing and review workstation, not an IVD.
N/A
Intended Use / Indications for Use
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.
Product codes
LLZ
Device Description
XELERIS 2 PROCESSING AND REVIEW WORKSTATION (Xeleris 2) is a modification of the Xeleris (initially submitted under the name JUPITER PROCESSING AND REVIEW WORKSTATION, K024137), which was first introduced and marketed in 2003. Xeleris 2, is a computer workstation software used for the display, processing, filming, and communication of Emission Tomography and planar images (data) and hybrid imaging. As in Xeleris, it too includes capabilities to perform image corrections based on Attenuation Tomography and motion and to provide registration of anatomical and physiological images. It runs on Microsoft Windows XP based PC workstation (high resolution color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD and optical disk archive devices are also available. The system conforms to the following mandatory and voluntary standards:
- 21 CFR Subchapter J Radiation Standards for Monitors .
- IEC 60950 Safety of information technology equipment .
- IEC 60601-1-1 Safety requirements for medical electrical systems ●
- IEC 60601-1-2 Requirements for safety; Electromagnetic Compatibility. ●
- IEC 60601-1-4-Medical Electrical Equipment Part 1-4: General Requirements. t
- NEMA PS3, DICOM .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Emission Tomography, planar imaging
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
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Key Metrics
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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K051678
Page 1 of 2
JUL 1 8 2005
Image /page/0/Picture/2 description: The image shows the GE Medical System logo. The logo consists of a circular emblem with the letters "GE" intertwined inside. Below the emblem, the text "GE Medical System, F.I., Haifa" is printed in a simple, sans-serif font. The text provides the name of the company and its location.
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)
| Submitter: | GE Medical Systems
3000 N. Grandview Blvd.
Waukesha, WI 53188 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laurence Bigio
Quality, Safety and Regulatory Manager
Telephone: +972-4-856-3663; Fax: +972-4-857-7664 |
| Date Prepared: | June 24, 2005 |
| Device Name: | XELERIS 2 PROCESSING AND REVIEW WORKSTATION
System, Image Processing, Radiological, 21 CFR 892.2050, 90-LLZ |
| Marketed Device: | GE MEDICAL SYSTEM'S XELERIS PROCESSING AND REVIEW
WORKSTATION; 510(k) Number K024137, currently in commercial
distribution (first introduced under the name Jupiter). |
Device Description:
XELERIS 2 PROCESSING AND REVIEW WORKSTATION (Xeleris 2) is a modification of the Xeleris (initially submitted under the name JUPITER PROCESSING AND REVIEW WORKSTATION, K024137), which was first introduced and marketed in 2003. Xeleris 2, is a computer workstation software used for the display, processing, filming, and communication of Emission Tomography and planar images (data) and hybrid imaging. As in Xeleris, it too includes capabilities to perform image corrections based on Attenuation Tomography and motion and to provide registration of anatomical and physiological images. It runs on Microsoft Windows XP based PC workstation (high resolution color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD and optical disk archive devices are also available. The system conforms to the following mandatory and voluntary standards:
- 21 CFR Subchapter J Radiation Standards for Monitors .
- IEC 60950 Safety of information technology equipment .
- IEC 60601-1-1 Safety requirements for medical electrical systems ●
- IEC 60601-1-2 Requirements for safety; Electromagnetic Compatibility. ●
- IEC 60601-1-4-Medical Electrical Equipment Part 1-4: General Requirements. t
- NEMA PS3, DICOM .
Indications for Use:
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.
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KOSle B
Page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for GE Medical System, F.I., Haifa. The logo consists of the letters "GE" in a stylized font, enclosed in a circle. The text "GE Medical System, F.I., Haifa" is printed below the logo. The text is in a simple, sans-serif font.
Comparison with Predicate Device:
The GE XELERIS 2 PROCESSING AND REVIEW WORKSTATION is a modification of, and is comparable and substantially equivalent to the currently marketed GE XELERIS PROCESSING AND REVIEW WORKSTATION (first introduced under the name Jupiter - K024137). This system has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.
Summary of Studies:
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Conclusion:
Intended use and fundamental scientific technology are the same as the legally marketed GE XELERIS PROCESSING AND REVIEW WORKSTATION. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/EN 46001 and ISO 13485 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the XELERIS 2 PROCESSING AND REVIEW WORKSTATION is substantially equivalent to the currently cleared XELERIS PROCESSING AND REVIEW WORKSTATION-K024137.
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Image /page/2/Picture/1 description: The image is a seal or logo. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a stylized image of three birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2005
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems W-709 P.O. Box 414 MILWAUKEE WI 53201
Re: K051673
Trade/Device Name: XELERIS 2 Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 20, 2005 Received: June 23, 2005
Dear Dr. Kroger:
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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w Jours of substantial equivalence of your device to a legally prematication. The PDF mailing of Station 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 If you deathe specific da ne of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, production other general information on your responsibilities under the Act from the 807.77). Tou may obtain ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
Image /page/4/Picture/0 description: The image shows the logo for GE Medical System, F.I., Haifa. The logo consists of the GE monogram in a circle on the left, followed by the text "GE Medical System, F.I., Haifa" on the right. The text is in a simple, sans-serif font and is aligned with the bottom of the GE monogram.
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: XELERIS 2 PROCESSING AND REVIEW WORKSTATION
Indications for Use
The display, processing, archiving, and communication of data acquired by Emission The display, processing, aronting, and ology, including procedures for planar romography camoras dood in alagnessblic (SPECT) imaging, positron imaging by intaging, attenuation correction, and anatomical image registration.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801-109)
Over-The-Counter Use
Nancy Broglon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051673
Special 510(k) Premarket Notification
XELERIS 2 PROCESSING AND REVIEW WORKSTATION