K051673 · GE Medical Systems · LLZ · Jul 18, 2005 · Radiology
Device Facts
Record ID
K051673
Device Name
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
Applicant
GE Medical Systems
Product Code
LLZ · Radiology
Decision Date
Jul 18, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
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.
Device Story
Xeleris 2 is a computer workstation software for display, processing, archiving, and communication of Emission Tomography, planar, and hybrid imaging data. It functions as a modification of the Xeleris (Jupiter) workstation. The system processes inputs from Emission Tomography cameras, performing image corrections (attenuation, motion) and anatomical/physiological image registration. It operates on a Windows XP-based PC with a high-resolution monitor, keyboard, mouse, and CD-RW/DVD/optical disk archiving. Used in clinical settings by healthcare professionals to review images, the output facilitates diagnostic decision-making by providing processed, registered, and corrected radiological images. The device supports clinical workflows through Ethernet network connectivity and DICOM standards.
Clinical Evidence
Bench testing only. The device was evaluated for electrical, mechanical, and radiation safety, confirming conformance to applicable standards (IEC 60950, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4). No clinical data was required or provided.
Technological Characteristics
PC-based workstation running Microsoft Windows XP. Includes high-resolution color monitor, keyboard, mouse, and CD-RW/DVD/optical disk archiving. Connectivity via Ethernet and DICOM (NEMA PS3). Conforms to IEC 60950, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-4 standards. Software-based image processing for attenuation correction, motion correction, and image registration.
Indications for Use
Indicated for the display, processing, archiving, and communication of diagnostic radiology data from Emission Tomography cameras, including planar, whole body, SPECT, and positron imaging, as well as attenuation correction and anatomical image registration.
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
GE XELERIS PROCESSING AND REVIEW WORKSTATION (K024137)
Submission Summary (Full Text)
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K051678
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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<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laurence Bigio<br>Quality, Safety and Regulatory Manager<br>Telephone: +972-4-856-3663; Fax: +972-4-857-7664 |
| Date Prepared: | June 24, 2005 |
| Device Name: | XELERIS 2 PROCESSING AND REVIEW WORKSTATION<br>System, Image Processing, Radiological, 21 CFR 892.2050, 90-LLZ |
| Marketed Device: | GE MEDICAL SYSTEM'S XELERIS PROCESSING AND REVIEW<br>WORKSTATION; 510(k) Number K024137, currently in commercial<br>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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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.
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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
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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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
