K963952 · Ge Dec Medical Systems · OWB · Dec 23, 1996 · Radiology
Device Facts
Record ID
K963952
Device Name
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
Applicant
Ge Dec Medical Systems
Product Code
OWB · Radiology
Decision Date
Dec 23, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
The Series 9600 Mobile Digital Imaging System 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 unit (x-ray generator, tube, image intensifier) and mobile workstation (monitors, image processing, storage). Used in hospitals and clinics by physicians, surgeons, cardiologists, radiologists, and technologists. Performs linear/rotational motions for patient positioning. Captures x-ray inputs; processes and displays images for real-time visualization during procedures. Supports peripheral interfaces (printers, VCRs). Facilitates diagnostic, surgical, and interventional guidance; aids clinical decision-making via immediate visual feedback.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance with 21 CFR 1020.30-32 and international safety standards (IEC 601 series, UL 187, CSA-C22.2) serves as evidence of safety and effectiveness.
Indicated for fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room applications. No specific age or gender contraindications stated.
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 (original 510(k) device)
Philips Medical Systems - BV 29 Mobile Imaging System
Philips Medical Systems - BV 212 Mobile Imaging System
Submission Summary (Full Text)
{0}
OEC
OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY, UTAH 84116
801-328-9300
FAX 801-328-4300
K963952
P1n/3
DEC 23 1996
# 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:
September 27, 1996
## 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:
Series 9600 Mobile Digital Imaging System (modified - Phase III)
## Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified
## Common/Usual Names:
Fluoroscopic Imaging System
Mobile C-arm
Page 1-SUM
{1}
September 1996
510(k) Summary
Modified Series 9600 Mobile Digital Imaging System
K963952
P293
## Substantial Equivalence:
The modified Series 9600 Mobile Digital Imaging System is substantially equivalent to the following systems which are currently marketed:
- OEC Medical Systems - Series 9600 Mobile Digital Imaging System [original 510(k) device]
- Philips Medical Systems - BV 29 Mobile Imaging System
- Philips Medical Systems - BV 212 Mobile Imaging System
All of these devices are mobile C-arm type diagnostic x-ray systems intended for fluoroscopic imaging. The systems all include a high-voltage x-ray generator, x-ray tube, image intensifier, video image displays, digital image processing and image storage capability.
## Device Description:
### Indications For Use
The Series 9600 Mobile Digital Imaging System 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.
### User Characteristics
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists. The device is used in hospitals, out-patient clinics and other clinical environments to provide fluoroscopic and spot-film imaging during diagnostic, surgical and interventional procedures. 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 Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a “C” shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The C-arm 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.
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.
Page 2-SUM
{2}
September 1996
510(k) Summary
Modified Series 9600 Mobile Digital Imaging System
K963952
p 3073
# Standards:
In addition to complying with the Federal Performance Standard for Diagnostic X-ray Systems (21 CFR §1020.30-32), the modified Series 9600 Mobile Digital Imaging System is designed in accordance with guidelines established in the following standards:
- ANSI/NFPA 99, Standard for Health Care Facilities
- ANSI/NFPA 70, National Electrical Code
- UL 187, Standard for X-ray 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
- 93/42/EEC - Annex 1, Essential Requirements of the Medical Devices Directive
This concludes this 510(k) Summary.
Ted L. Parrot,
Vice President, Quality Assurance/Regulatory Affairs
OEC Medical Systems, Inc.
Page 3-SUM
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.
