K122234 · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · OWB · Aug 16, 2012 · Radiology
Device Facts
Record ID
K122234
Device Name
OEC 9900 ELITE
Applicant
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
Product Code
OWB · Radiology
Decision Date
Aug 16, 2012
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.1650
Device Class
Class 2
Indications for Use
The OEC® 9900 Elite 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.
Device Story
OEC 9900 Elite is a mobile fluoroscopic X-ray system used by physicians to visualize patient anatomy during surgical and interventional procedures. It provides real-time X-ray imaging and records of pre-surgical, intra-operative, and post-surgical anatomy. The system assists in localizing surgical regions of interest and visualizing pathology. Modifications include an alternative X-ray tube, alternative radiological imaging unit (RIU/image intensifier), optional wireless connectivity to hospital PACS, consolidated printed circuit board assemblies, and optional wireless foot/hand switches. The device is operated by trained clinicians in clinical settings such as ORs, critical care, and emergency rooms. Output is displayed for physician review to guide clinical decision-making and surgical intervention.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and verification activities confirming that modified components (X-ray tube, RIU, wireless platform, PCB, switches) meet the same specifications as the predicate device.
Technological Characteristics
Mobile fluoroscopic X-ray system. Components: X-ray tube, radiological imaging unit (image intensifier). Connectivity: Optional wireless platform for PACS integration. Control: Optional wireless foot/hand switches. Hardware: Consolidated printed circuit board assemblies. Compliance: Voluntary standards as detailed in submission.
Indications for Use
Indicated for patients undergoing diagnostic, surgical, and interventional procedures requiring fluoroscopic and spot-film imaging, including cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures.
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.
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K122234
AUG 16 2012
GE Healthcare 510(k) Premarket Notification Submission
### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: August 3, 2012
Submitter:
GE Healthcare Surgery 384 Wright Brothers Drive Salt Lake City, UT 84116
Primary Contact Person:
Gerald Buss Director Regulatory Affairs GE Healthcare Surgery Phone: (801) 517-6591 Fax: (801) 517-6566
Secondary Contact Person:
Karen Russell Regulatory Affairs Leader GE Healthcare Surgery Phone: (801) 536-4930 Fax: (801) 517-6566
Device: (Trade Name): Common/Usual Name: Classification Names:
Mobile Fluoroscopic Imaging System
K120613 OEC® 9900 Elite
OEC® 9900 Elite
21 CFR 892.1650 Image-intensified fluoroscopic x-ray system
Product Code: 900XO, 90JAA, and OWB
Predicate Device(s):
Device Description:
The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a medical procedure. Images from the system help the physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and The images provide real-time visualization and pathology. records of pre-surgical anatomy, in vivo-surgical activity and post-surgical outcomes.
The proposed device will add an alternative supplier for the X-Ray The current tube and the proposed tube have the same Tube. specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.
The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The
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# GE Healthcare
## 510(k) Premarket Notification Submission
current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.
The proposed device will provide an optional wireless service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.
Two printed circuit board assemblies have been combined into a single board in the proposed device. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.
#### Intended Use:
Technology:
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 OEC® 9900 Elite Mobile Fluoroscopy System is designed to
The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the proposed device.
Verification testing has confirmed that the OEC® 9900 Elite and its application comply with voluntary standards as detailed in Section 9, of this premarket submission. The modifications from the predicate device OEC® 9900 Elite were completed in accordance with GE Healthcare Surgery's quality management system design controls. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks. Information is included with this 510(k) submission that supports this determination.
GE Healthcare considers the modified GE OEC® 9900 Elite to be Conclusion: as safe, as effective, and perform substantially equivalent to the predicate device OEC® 9900 Elite (K 120613).
Determination of Substantial Equivalence:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 16 2012
Mr. Gerald Buss Director Regulatory Affairs GE Healthcare Surgery (GE OEC Medical Systems, Inc.) 384 Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K122234
Trade/Device Name: GE OEC 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. OXO. and JAA Dated: July 20, 2012 Received: July 26, 2012
Dear Mr. Buss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >><(x) promation 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 Caclosure) to 1egarry mannet date of the Medical Device Amendments, or to commerce province to May 26, 1976, the encomment with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to not require apple to the general controls provisions of the Act. The 1 ou may, merciole, market the device, ecolde requirements for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is Classificu (sec above) into exase fr (sign your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poderal Free ming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subsidination with other requirements of the Act that FDA has made a dectrimation that your as receiner Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 Comply with an the 11et 5 requirements 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practices and Incurements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witi anow you to oogin finding of substantial equivalence of your device to a legally marketed nouthoution. The FDF imally of fication 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 Parts 801 and II you desire specific an rice for your ac-receive ex-res-evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise, process not 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may other belief one general management and Consumer Assistance at its toll-free number (800) 638-2041 of (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours. Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.
# GE Healthcare 510(k) Premarket Notification Submission
## INDICATIONS FOR USE
510(k) Number (if known):
Device Name: GE OEC 9900 Elite
Indications for Use:
The OEC® 9900 Elite 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, vascular, cardiac, critical care and emergency room procedures.
Prescription Use_ ✔ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
K122234
් පොකොට
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.
