INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
K974355 · Ge Dec Medical Systems · OWB · Feb 17, 1998 · Radiology
Device Facts
Record ID
K974355
Device Name
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
Applicant
Ge Dec Medical Systems
Product Code
OWB · Radiology
Decision Date
Feb 17, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Device Story
Mobile C-arm fluoroscopic imaging system; consists of C-arm stand (x-ray tube, image intensifier, high-voltage generator) and mobile workstation (display monitors, image processing/storage). Used in hospitals, clinics, and emergency settings by physicians, surgeons, cardiologists, radiologists, and technologists. Captures x-ray images for real-time visualization during procedures; supports linear/rotational positioning. Workstation processes and displays images; provides interfaces for printers, VCRs, and Medrad angiographic injectors. Facilitates clinical decision-making by providing intraoperative imaging guidance. Benefits include improved visualization during minimally invasive and surgical interventions.
Clinical Evidence
No clinical data provided; bench testing only. Device safety and effectiveness are supported by compliance with established performance standards for diagnostic x-ray systems and medical electrical equipment.
Technological Characteristics
Mobile C-arm x-ray system. Components: high-voltage generator, x-ray tube, image intensifier. Connectivity: DICOM 3.0, RS-170/CCIR video outputs, auxiliary port for angiographic injectors. Standards: 21 CFR 1020.30-32, ANSI/NFPA 70/99, UL 2601, CSA-C22.2 No. 601.1-M90, IEC 601-1, IEC 601-1-2, IEC 601-1-3, IEC 601-2-7, IEC 601-2-32.
Indications for Use
Indicated for patients requiring fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopic, 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 Medical Systems SERIES 9600® Mobile Digital Imaging System
Philips Medical Systems BV 300 Series Mobile C-arm System
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" in a bold, sans-serif font, with three horizontal lines replacing the horizontal bar of the "E". Below the letters, the words "OEC MEDICAL SYSTEMS, INC." are printed in a smaller, sans-serif font.
381 WRICHU BROMERS DRIVE
SALI LARE CHY. ប់ ប្រព័ន្ធព្រៃច
801-328-9300 FAX 801 328 4000
K974355
FEB 1 7 1998
# 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:
November 14, 1997
# Name of Submitter:
OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300
# Corresponding Official:
Ted L. Parrot, Vice President, Quality/Regulatory Affairs.
# Device Proprietary Name:
Interventional Mobile Digital Imaging System (herein called IMDIS)
## Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified - or System, X-ray, Mobile
# Common/Usual Names:
Mobile C-arm, Fluoroscopic Imaging System
{1}------------------------------------------------
#### Substantial Equivalence:
The IMD/S is substantially equivalent to the following devices which are currently marketed:
- OEC Medical Systems SERIES 9600® Mobile Digital Imaging System .
- Philips Medical Systems BV 300 Series Mobile C-arm System .
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems all include a high-voltage x-ray generator and control, x-ray tube, image intensifier, video image displays, digital image processing and image storage capability, as well as conventional spot-film capability.
#### Device Description:
#### Indications For Use
The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
## User Characteristics
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained by OEC applications specialists and/or qualified site personnel in the proper use of the device. The device labeling stipulates that only properly trained persons operate this equipment.
#### General Description
The IMDIS is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus which supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. 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 Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media iniection.
{2}------------------------------------------------
## Standards:
The IMDIS is designed in accordance with product safety requirements established in the following standards:
- · Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32)
- · ANSI/NFPA 70 & 99 National Electrical Code and Standard for Health Care Facilities
- · UL 2601 Medical Electrical Equipment
- CSA-C22.2 No. 601.1-M90 . Medical Electrical Equipment
- · IEC 601-1. Medical Electrical Equipment, General Requirements for Safety
- · IEC 601-1-2. Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
- · IEC 601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- · IEC 601-2-7, Medical Electrical Equipment, Safety of HV/X-ray Generators
- . IEC 601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
- 93/42/EEC Annex 1 . Essential Requirements of the Medical Devices Directive
This concludes this 510(k) Summary.
Hamot
Ted L. Parrot, Vice President, Quality Assurance/Regulatory Affairs OEC Medical Systems, Inc.
TLP/jw
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of a stylized eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 1998
Ted L. Parrot Vice President, Quality Assurance/ Regulatory Affairs and Official Correspondent OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, Utah 84116
Re: K974355 Interventional Mobile Digital Imaging System Dated: November 14, 1997 Received: November 19, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1720/Procode: 90 IZL
Dear Mr. Parrott:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". _
Sincerely vours.
William Yu
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Notification
# Indications For Use Statement
| Applicant: | OEC Medical Systems, Inc. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. (if known): | K974355 |
| Device name: | Interventional Mobile Digital Imaging System (IMDIS) |
| Indications for use: | The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. |
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)
C. Lejser
(Division Sign-Off) < Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
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.
