K041932 · Ge Oec Medical Systems, Inc. · OWB · Aug 18, 2004 · Radiology
Device Facts
Record ID
K041932
Device Name
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
Applicant
Ge Oec Medical Systems, Inc.
Product Code
OWB · Radiology
Decision Date
Aug 18, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Device Story
Mobile C-arm fluoroscopy system; consists of C-arm (x-ray tube, generator, image intensifier) and mobile workstation (monitors, image processing/recording). Performs linear/rotational motions for patient positioning. Used in OR, clinic, or emergency settings by physicians/technicians. Inputs: X-ray radiation; Outputs: Fluoroscopic/spot-film images displayed on monitors. Supports peripheral integration (printers, VCRs) and angiographic injector synchronization. DICOM 3.0, RS-170, and CCIR video output compatibility. Assists clinicians in real-time visualization during procedures; facilitates diagnostic/interventional decision-making.
Clinical Evidence
Bench testing only. No clinical data provided. Device safety and performance verified through compliance with recognized international standards including IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), and IEC 60601-1-4 (Programmable Electrical Medical Systems).
Indicated for patients requiring fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room applications.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
OEC 9800 Plus Digital Mobile Imaging System (K021049)
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Koti937
## AUG 1 8 2004
#### 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Date: | July 14, 2004 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Submitter: | GE OEC Medical Systems, Inc.<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116<br>801-536-4668 |
| Corresponding Official: | Jeff Wagner<br>Manager, Regulatory Affairs |
| Device Proprietary Name: | OEC Olympus Mobile Fluoroscopy System |
| Classification Name: | Image Intensified Fluoroscopic X-ray System with Image<br>Processing System |
| Common/Usual Names: | Fluoroscopic Imaging System |
| Substantial Equivalence: | The OEC Olympus Mobile Fluoroscopy System is substantially<br>equivalent to the:<br>• OEC 9800 Plus Digital Mobile Imaging System (K021049)<br>marketed by GE OEC Medical Systems, Inc.<br>• OEC 9800 E/CV+ Digital Mobile Systems (K024012)<br>marketed by GE OEC Medical Systems, Inc. |
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#### Indications for Use
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
#### General Description
The OEC Olympus Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the xray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCR's. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets and DICOM 3.0. An auxiliary connection is provided for a angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.
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#### Product Standards
The OEC Olympus Mobile Fluoroscopy System is designed in accordance with product safety and performance requirements established in the following standards:
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|-----------------------------|---------------------------------------------------------------------------|
| ANSI/NFPA 70 & 99 | National Electrical Code and Standard for Health Care Facilities |
| UL 60601 | Medical Electrical Equipment |
| CSA-C22.2 No. 601.1-<br>M90 | Medical Electrical Equipment |
| IEC 60601-1 | Medical Electrical Equipment, General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment, Electromagnetic Compatibility |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic<br>X-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical<br>Systems |
| IEC 60601-2-7 | Medical Electrical Equipment, HV/X-ray Generators |
| IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tube and Source Assemblies |
| IEC 60601-2-32 | Medical Electrical Equipment, Safety of Associated X-ray<br>Equipment |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |
This concludes this 510(k) Summary.
GE OEC MEDICAL SYSTEMS, INC.
Jeff Wagner
Jeff Wagner Manager, Regulatory Affairs
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### AUG 1 8 2004
Mr. Jeff Wagner Manager, Regulatory Affairs GE OEC Medical Systems, Inc. General Electric Company 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862 Re: K041932 Trade/Device Name: OEC Olymups Mobile Fluoroscopy System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 JAA and IZL Dated: July 14, 2004 Received: July 19, 2004
Dear Mr. Wagner:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviously four over wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or provision to may 20, 2017 accordance with the provisions of the Federal Food, Drug, devices that have ooon require approval of a premarket approval application (PMA). and Cosmolo Flor (110.) that the device, subject to the general controls provisions of the Act. The r ou may, iter erovisions 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 If your device is elabilion (von a 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 that I Dri has hastou a severations administered by other Federal agencies. You must comply of any I back is 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 quality by sentrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought marketing of substantial equivalence of your device to a legally premarket notheation. The PDA miding of easification 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 desire specific advice to your of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, for questions on the problems as a so, please note the regulation entitled, "Misbranding Other of Othphanos at ( notification" (21CFR Part 807.97) you may obtain. Other gencral by receive to premarked notificancer (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 14andfulerer of , meethant address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Boyden
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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## Indications For Use Statement
| Applicant: | GE OEC Medical Systems, Inc. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. (if known): | |
| Device name: | OEC Olympus Mobile Fluoroscopy System |
| Indications for use: | The OEC Olympus Mobile Fluoroscopy System is designed to provide<br>fluoroscopic and spot-film images of the patient during diagnostic,<br>surgical and interventional procedures. Examples of clinical application<br>may include cholangiography, endoscopy, urologic, orthopedic,<br>neurologic, vascular, cardiac, critical-care and emergency room<br>procedures. The system may be used for other imaging applications at<br>the physicians discretion. |
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|------------------------------------------|---|
|------------------------------------------|---|
OR
Over-The-Counter _______
(Optional Format 1-2-96)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K041932 |
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.
