The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
Device Story
O-Arm Imaging System is a mobile X-ray system providing 2D fluoroscopic and 3D volumetric imaging for intraoperative use in surgical theaters. System comprises two interconnected units: an X-ray stand with a power-assisted transport mechanism and a mobile viewing station. The X-ray stand features a C-shaped rotor housed within an enclosed, full-circle 'O' configuration; this rotor utilizes high-precision robotics to orient the X-ray source and flat-panel digital detector to specific trajectories, allowing for automated return to saved positions. The viewing station processes images and provides a user interface for image/patient management. Surgeons use the system to obtain real-time 2D fluoroscopy or 3D reconstructions to assist in orthopedic procedures; the system is compatible with certain Image Guided Surgery Systems. By providing high-precision, automated 3D imaging intraoperatively, the device assists clinicians in surgical navigation and decision-making, potentially improving procedural accuracy.
Clinical Evidence
Bench testing only. A concurrence study compared 31 pairs of 2D fluoroscopic and 3D images of identical cadaveric anatomical structures acquired using the O-Arm and the Siemens ISO-C C-Arm. A radiologist evaluated the images and determined that the O-Arm and predicate device provide equivalent diagnostic capability.
Technological Characteristics
Mobile X-ray system with power-assisted transport. Features a full-circle housing containing a C-shaped rotor for 360-degree imaging. Uses a flat-panel digital X-ray detector. Employs robotic positioning for the internal rotor. System is comprised of an X-ray stand and a separate mobile viewing station. Connectivity includes compatibility with Image Guided Surgery Systems.
Indications for Use
Indicated for 2D fluoroscopic and 3D imaging during intraoperative surgical procedures, specifically orthopedic applications. Intended for use in surgical theaters.
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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K050996
### MAY - 5 2005
### 510(k) Summary for the O-Arm™ Imaging System (4/01/05)
### Submittal information:
Wolfgang Krull Breakaway Imaging, LLC 300 Foster Street Littleton, MA 01460
Phone: 978-952-2990
#### Device name and classification
| Proprietary Name: | O-Arm™ Imaging System |
|-----------------------|-----------------------------------------------|
| Classification Names: | Mobile X-ray System, Solid-state X-ray Imager |
| Classification Panel: | Radiology |
| CFR Sections: | 21 CFR 892.1720, 21 CFR 892.1650 |
| Class: | II |
| Product Codes: | OXO |
#### Substantial Equivalence
The O-Arm™ Imaging System is substantially equivalent to the Siemens SIREMOBIL Iso-C30, which was cleared in 510(k)'s K032280 and K003266.
# Device Description
The O-Arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging.
The system consists of two parts: the x-ray O-Arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors).
#### Intended Use
The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
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### 510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued
### Comparison with the Predicate Device
KOSO996
#### O-Arm™ Imaging System A portable system with separate Physical viewing station. The imaging configuration unit is full circle or "O-arm". 3-D imaging Imaging modes 2-D fluoroscopy Intraoperative imaging Intended use
SIREMOBIL Iso C3D A portable system with separate viewing station. The imaging unit is a 190ºC-arm.
3-D imaging 2-D fluoroscopy Intra-operative imaging.
### Similarities and Differences
Both devices perform both 2-D fluoroscopy and 3-D volumetric imaging.
The mechanical configuration of both devices allows a lateral approach to the patient. The predicate device has a c-arm configuration, mounting the source and detector on distal ends of the 'C'. The O-Arm™ mounts the imaging components on a c-shaped rotor inside of an enclosed, full circle housing. The O-Arm™ housing is opened to approach the patient.
For 2-D imaging with the predicate device, the user manually orients the source and detector for the needed image trajectory. The O-arm™ utilizes high-precision robotics to orient the internal rotor to the proper trajectory. To return to a position, the Siemens user manually repositions the 'C'. With its robotic positioning, the O-arm™ automatically returns to positions "saved" by the user.
For 3-D imaging, the predicate device drives the 'C' in a circumferential movement through a 190° arc. The O-Arm™ drives the internal C-shaped rotor through a 360° arc inside the enclosed housing.
Both systems have two mobile, interconnected units: an X-ray stand and a mobile viewing station. Both units of the predicate device are moved manually. The O-Arm™ X-ray Stand has a power-assisted transport mechanism.
Both systems are configured with opposing x-ray source and x-ray detector. The sources are similar. The predicate device uses a circular image intensifier tube as the detector, while the O-Arm™ uses a rectangular flat panel digital detector. As a result, the images are displayed differently. In 2-D, the image intensifier displays a circular image, and the flat panel displays a rectangular image. In 3-D, the image intensifier reconstructs to a volumetric sphere, while the O-arm™ reconstructs to a volumetric cylinder. X-ray beam collimation, available in both systems, allow the user to select the area or volume to best fit the application.
Breakaway Imaging, LLC - - -
Q-Arm™ Imaging System 510(k)
Page 5
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## 510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued
Koso996
### Assessment of Performance Data
A concurrence study was performed comparing images of the same anatomical structure made with a Siemens ISO-C C-Arm Imaging System and with the O-Arm™ Imaging System. The imaged subject was a cadaver allowing virtually identical sites to be imaged by both systems. Sites were selected to include common orthopedic procedure locations. Thirty one pairs of images, including 3-D and fluoroscopic images, were evaluated. The fluoroscopic images were evaluated "live". Both the O-Arm and the predicate device have a feature that freezes the last image of a fluoroscopic series. The 3-D images and the "frozen" last images last images were submitted with the 510(k).
A radiologist evaluated the images during the study. He determined that for all image pairs, the images from the O-Arm™ and the predicate device are of equivalent diagnostic capability.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three figures in profile facing right. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Breakaway Imaging, LLC % Mr. Jeff Rongero Senior Project Engineer/Program Reviewer Conformity Assessment Services Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747-3081
NOV 1 7 2011
Re: K050996
Trade/Device Name: O-Arm Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: April 18, 2005 Received: April 20, 2005
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of May 5, 2005.
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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Michael D O'Hern for
Mary S. Pastel. Sc.D. 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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### Indications for Use
510(k) Number (if known): __N/A_______________________________________________________________________________________________________________________________________________
Device Name: ____ O-Arm™ Imaging System_______________________________________________________________________________________________________________________________________
Indications for Use:
The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for The O-Atin - Intagring of Stein is in surgical theaters, particularly for orthopedic mirations. The O-Arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
ﯩﻴ
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.
