(58 days)
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One CFD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.
The subject device is labelled as OEC One CFD.
Here's a summary of the acceptance criteria and the study details for the OEC One CFD device, specifically focusing on the new "Deep learning-based Trajectory Pointer software" feature, as that's where the most detailed study information is provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance (for Trajectory Pointer)
| Feature/Metric | Acceptance Criteria (MAAP) | Reported Device Performance |
|---|---|---|
| Trajectory Pointer Success Rate (Last Image Hold images) | At least 95% of test dataset should have a Dice score above 0.9 | 98.8% with a 95% confidence level |
| Trajectory Pointer Success Rate (Fluoroscopy images) | At least 95% of test dataset should have a Dice score above 0.9 | 97.1% with a 95% confidence level |
2. Sample Size Used for the Test Set and Data Provenance
- Total image dataset: 3078 images
- Test set size: 307 images (approx. 10% of the total dataset)
- Data Provenance (Ethnicity/Country):
- US: 51.1%
- China: 35.8%
- Phantom: 9.8%
- EU/Australia: 3.3%
- Data type: The document states that sample clinical images were evaluated to demonstrate substantial equivalence, and "all images were collected from GE OEC Mobile C-arm devices," suggesting retrospective collection of clinical images, alongside phantom data. It also notes that the test data covers the "entire range of values for all confounders," implying it's representative of real-world scenarios.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 3
- Qualifications: U.S. board-certified radiologists. (No specific years of experience are listed).
4. Adjudication Method for the Test Set
- The document states: "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."
- This implies a consensus or verification process by multiple experts to validate the initial manual annotations, but a specific method like "2+1" or "3+1" is not explicitly mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The performance metrics reported are for the algorithm's standalone performance.
6. If a Standalone (Algorithm Only) Performance Study was Done
- Yes, a standalone performance study was done for the Trajectory Pointer feature. The reported success rates of 98.8% for LIH images and 97.1% for Fluoroscopy images (both exceeding the 95% MAAP) are measures of the algorithm's performance.
7. The Type of Ground Truth Used
- For the Trajectory Pointer feature, the ground truth was established by expert consensus/manual annotation. Specifically, "the contours of K-wires were manually outlined by trained annotators," and "3 U.S. board certified radiologists check annotations to make sure the ground truth is correct."
8. The Sample Size for the Training Set
- Training set size: 2771 images (3078 total images - 307 test images = 2771 images). The document states: "Total dataset included 3078 images, 307 were used for test dataset and the rest for training/tuning."
9. How the Ground Truth for the Training Set was Established
- While not explicitly detailed for the training set, it is highly probable that the ground truth for the training data was established in a similar manner to the test set: through manual outlining of K-wire contours by trained annotators. The document mentions "comparing ground truth annotations" during deduplication, implying annotations were available for the training data.
FDA 510(k) Clearance Letter - OEC One CFD
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
November 26, 2025
GE Hualun Medical Systems Co., Ltd
℅ Lifeng Wang
Regulatory Affairs Manager
No. 1 Yong Chang North Road, Economic Technological
Development Zone Beijing,
BEIJING 100176
CHINA
Re: K253269
Trade/Device Name: OEC One CFD
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OXO, JAA, OWB
Dated: September 29, 2025
Received: September 29, 2025
Dear Lifeng Wang:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 contract 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.
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K253269 - Lifeng Wang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253269 - Lifeng Wang
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K253269
Device Name: OEC One CFD
Indications for Use (Describe):
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
GE Healthcare 510(k) Premarket Notification Submission – OEC One CFD
Page 1 of 14
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: November 26, 2025
Submitter: GE HUALUN MEDICAL SYSTEMS CO., Ltd
No. 1 Yong Chang North Road,
Beijing Economic Technological Development Zone,
Beijing 100176 China
Primary Contact: Lifeng Wang
Regulatory Affairs Manager- IGT
Tel: +8613381164329
e-mail: lifeng.wang@gehealthcare.com
Secondary Contacts: Bryan Behn
Sr. Director - Regulatory Affairs
GE HealthCare
Tel: (262) 2475502
e-mail: Bryan.Behn@gehealthcare.com
PRODUCT IDENTIFICATION
| Device Trade Name: | OEC One CFD |
|---|---|
| Regulation Name: | Image-intensified Fluoroscopic x-ray system |
| Classification Panel: | Radiology |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OXO |
| Subsequent Product Codes | JAA, OWB |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., LtdNo. 1 Yong Chang North Road, Beijing EconomicTechnological Development Zone,Beijing 100176 China |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
Primary Predicate Device:
| Device Trade Name: | OEC One ASD |
|---|---|
| 510(k) number: | K240828 |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OXO |
| Subsequent Product Codes | JAA, OWB |
| Manufacturer: | GE HUALUN MEDICAL SYSTEMS CO., LtdNo. 1 Yong Chang North Road, Beijing EconomicTechnological Development Zone,Beijing 100176 China |
Reference Device
| Device Trade Name: | OEC Elite |
|---|---|
| 510(k) number: | K172550 |
| Regulation: | 21CFR 892.1650 |
| Classification: | Class II |
| Product Code: | OXO |
| Subsequent Product Codes | JAA, OWB |
| Manufacturer: | GE OEC Medical SystemsInc 384 Wright Brothers DriveSalt Lake City, Utah 84116 |
Device Description:
The OEC One CFD is a mobile C-arm X-ray system to provide fluoroscopic images of the patient during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures. These images help the physician visualize the patient's anatomy and localize clinical regions of interest. The system consists of a mobile stand with an articulating arm attached to it to support an image display monitor (widescreen monitor) and a TechView tablet, and a "C" shaped apparatus that has a flat panel detector on the top of the C-arm and the X-ray Source assembly at the opposite end.
The OEC One CFD is capable of performing linear motions (vertical, horizontal) and rotational motions (orbital, lateral, wig-wag) that allows the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy to be imaged. The C- arm is mechanically balanced allowing for ease of movement and capable of being "locked" in place using a manually activated lock.
The subject device is labelled as OEC One CFD.
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
Proposed Device Modification:
The modified OEC One CFD employs the same fundamental scientific technology as that of the unmodified predicate device (K240828). The primary change for the subject device is to introduce the optional Image Stitching and Deep learning-based Trajectory Pointer software features.
Indications for Use:
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
The intended use and indications for use are unchanged from the predicate device.
Technology:
The indications for use are identical and the technology is similar to the predicate device. The primary change on the subject device is to introduce the optional Image Stitching and Deep learning-based Trajectory Pointer software features.
Table 1 below summarizes the main feature/technological differences and similarities between the predicate device and the proposed device.
Table 1 Comparison between the Subject Device and Predicate Device
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| Image Receptor | 21cm Amorphous Silicon (aSi) Flat Panel Detector | 21cm and 31cm CMOS Flat Panel Detector | Substantially Equivalent.The change of the image receptor is to enhance the device performance.Both detector technology is widely used in mobile fluoroscopic C-arm imaging system.Also see comparation with the cleared reference device OEC Elite (K172550) that using the identical CMOS detectors in Table 2 in the following sectionThis change did not raise any new safety and effectiveness concerns. |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| Image Matrix Size | 21cm: 1520×1520 | 21cm: 1536x149631cm: 1548x1524 | Substantially Equivalent.Slightly changed for 21cm Flat Panel Detector (FPD).The image matrix size is determined by the physical dimensions of the detector.31cm FPD is larger than the 21 cm FPD, therefore it is different with OEC One ASD.This change did not raise any new safety and effectiveness concerns. |
| Monoblock | Type: Stationary Anode Focal Spot (IEC60336):-Small Focal: 0.6 x 1.4-Large Focal: 1.4Housing Heat Capacity: 900,000 HUHousing Cooling Rate: 12,500 HU/min | Type: Stationary Anode Focal Spot (IEC60336):-Small Focal: 0.6-Large Focal: 1.2Housing Heat Capacity: 1,200,000 HUHousing Cooling Rate: 20,000 HU/min | Substantial Equivalent.The focal spot size, heat capacity and cooling rate have been changed to enhance monoblock performance.The system verification and validation have been executed and passed.These changes did not raise any new safety and effectiveness concern. |
| X-ray Generation | 40 kHz High FrequencyMax Power 2.5 kWPeak Tube Potential: 40-110 kVpFluoroscopy: 0.1-8.0 mAHigh Level Fluoro: 0.2-25.0 mADigital Spot:2-10mA(for 100-120V system) | 20 kHz High FrequencyMax Power 4.0 kWPeak Tube Potential: 40-120 kVpFluoroscopy: 0.1-12.0 mAHigh Level Fluoro: 0.2-40.0 mADigital Spot:2-15mA(for 100-120V system) | Substantial Equivalent.The maximum power, kVp and mA updated to get the full capability of the tube insert to enhance the system performance.The frequency of the X-ray generator is adjusted to fit the 4kW max power.These changes are performance enhancement, and the X-ray generation |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| control mechanism is not changed.The system verification and validation have been executed and passed.These changes did not raise any new safety and effectiveness concern. | |||
| X-ray Control Modes | Auto ModeManual Mode(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Auto ModeManual Mode(Normal Fluoro, Low Dose Fluoro, High Level Fluoro) | Identical. |
| Imaging Modes | Continuous – Fluoroscopy-Normal Dose-High Level Dose-Low DosePulsed Fluoroscopy-Normal Dose-High Level Dose-Low DoseDigital Spot-Normal DoseSubtraction-Normal Dose-Low Dose | Continuous – Fluoroscopy-Normal Dose-High Level Dose-Low DosePulsed Fluoroscopy-Normal Dose-High Level Dose-Low DoseDigital Spot-Normal DoseSubtraction-Normal Dose-Low DoseRoadmap-Normal Dose-Low Dose | Substantially Equivalent.Roadmap provides a modified subtracted image on the left area of the monitor showing the difference between the current fluoroscopic image and a roadmap mask image.It is useful for providing the anatomical location of pathology for proper placement of a catheter, balloon, or stent.Roadmap function is the same as the cleared device OEC One (K182626).This change did not raise any new safety and effectiveness concerns. |
| Imaging Features | Auto X-Ray technique controlNoise and motion reduction (TNR)Auto/Manual Brightness and Contrast ControlNegateSwap and auto-swapSave and auto-saveLast image hold | Auto X-Ray technique controlNoise and motion reduction (TNR)Auto/Manual Brightness and Contrast ControlNegateSwap and auto-swapSave and auto-saveLast image hold | Identical. |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| Edge enhancementZoom (Live Zoom) & RoamImage rotationImage flip/ invertManual/Auto Smart MetalAutoTrakPatient AnnotationMarkersMeasurement FunctionsPeak OpacificationCine Recording/Playback· Cine Automatic Image Playback· Cine Frame-by-Frame Review· FluorostoreRe-RegistrationVariable LandmarkingMask save/RecallReference Image HoldDigital Pen | Edge enhancementZoom (Live Zoom) & RoamImage rotationImage flip/ invertManual/Auto Smart MetalAutoTrakPatient AnnotationMarkersMeasurement FunctionsPeak OpacificationCine Recording/Playback· Cine Automatic Image Playback· Cine Frame-by-Frame Review· FluorostoreRe-RegistrationVariable LandmarkingMask save/RecallReference Image HoldDigital Pen | Identical. | |
| Collimator | Iris, Tungsten Dual Leaf ShutterCollimator Iris PreviewCollimator Shutter PreviewSquircle shape secondary collimator | Iris, Tungsten Dual Leaf ShutterCollimator Iris PreviewCollimator Shutter PreviewSquircle shape secondary collimator | Identical. |
| Anti-scatter Grid | For 21cm detector:- Line Rate: 74L/cm- Ratio: 14:1- Focal Distance: 100 cm | For 21cm detector:- Line Rate: 74L/cm- Ratio: 14:1- Focal Distance: 100 cmFor 31cm detector:- Line Rate: 60L/cm- Ratio: 10:1- Focal Distance: 100 cm | Substantially Equivalent.Identical for 21cm grid.Adding 31cm grid due to the introduction of 31cm flat panel detector.This change did not raise any new safety and effectiveness concerns. |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| Image Shape | Squircle | Squircle | Identical. |
| Monitor Display | Colored 27" monitorResolution: 3840 x 2160Brightness: 600cd/m2Touch screen10 bit image display on monitor | Colored 27" monitorResolution: 3840 x 2160Brightness: 600cd/m2Touch screen10 bit image display on monitor | Identical. |
| Display Articulation | 180 degree swivel5 degrees tilt up25 degrees tilt downMonitor viewable from all 4 sidesHorizontal and Vertical viewing angle 178 degrees20cm up vertical travel20cm down vertical travelExtension arm rotation 210 degreesSpring arm rotation 180 degreesPosition monitor above C-arm by folding articulation arm within system footprint | 180 degree swivel5 degrees tilt up25 degrees tilt downMonitor viewable from all 4 sidesHorizontal and Vertical viewing angle 178 degrees20cm up vertical travel20cm down vertical travelExtension arm rotation 210 degreesSpring arm rotation 180 degreesPosition monitor above C-arm by folding articulation arm within system footprint | Identical. |
| Tech View Tablet | Size: 10.1 inchResolution: 1280 × 800 | Size: 12.1 inchResolution: 1280 × 800 | Substantially Equivalent.This change was driven by IT technology advancement by using a more state-of-the-art technology which achieves the same or better functionality.This change did not raise any new safety and effectiveness concerns. |
| Image Storage | 150,000 Images | 150,000 Images | Identical. |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| C-Arm Physical Dimensions | Free Space in Arc: 30.7" (78 cm)Depth of Arc: 26.0" (66 cm)Source Image Distance: 39.4" (100 cm)Lateral Rotation: 410° (+205° / -205°)Wig/Wag: 25° (+12.5°/-12.5°)Orbital Rotation: 150° (95° underscan /55° overscan)Horizontal Movement: 7.9" (20cm)Vertical Travel: 17.5" (44 cm) | Free Space in Arc: 30.7" (78 cm)Depth of Arc: 27.2" (69 cm)Source Image Distance: 39.4" (100 cm)Lateral Rotation: 410° (+205° / -205°)Wig/Wag: 25° (+12.5°/-12.5°)Orbital Rotation: 180° (95° underscan /90° overscan)Horizontal Movement: 7.9" （20cm）Vertical Travel: 17.5" (44 cm) | Substantial Equivalent.The depth of arc and the orbital rotation angle are changed to a larger range to make it easier for the user to use the system.These changes did not raise any new safety and effectiveness concern. |
| Printing | Wireless Printing ModulePrinters | Wireless Printing ModulePrinters | Identical. |
| Video Distributor | DP, BNC | DP, BNC | Identical. |
| Laser Aimer | Green LaserFlat panel detector side/Tube side Laser aimer:- CLASS 2 laser product- Wavelength: 510nm-530nmOptical output power: 1mW | Green LaserFlat panel detector side/Tube side Laser aimer:- CLASS 2 laser product- Wavelength: 510nm-530nmOptical output power: 1mW | Identical. |
| Image Processing | Noise and motion artifact reduction, Autotrak, ABS (based on CPU)Smart window, smart metal, ADRO (based on GPU) | Noise and motion artifact reduction, Autotrak, ABS (based on CPU)Smart window, smart metal, ADRO (based on GPU) | Identical |
| OEC One Touch Tableside | N/A | Tech View TabletIPX3 | Substantially Equivalent.The added optional OEC One Touch Tableside |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| provided identical function/feature that had already existed on the tablet on the system except for the ability to adjust the collimator during live X-rays.This change did not raise any new safety and effectiveness concerns. | |||
| Live Cast (wireless video) | N/A | Wireless video- Transmitter- Receiver-5.1-5.9 GHz | Substantially Equivalent.This feature is to introduce an optional wireless video module which enables the user to cast the system displays wirelessly to the selected external displays simultaneously. It functions in the same way as the cleared device OEC Elite (K172550).This change did not raise any new safety and effectiveness concerns. |
| OEC Display Cart | 27" monitorResolution: 1920X1080Non-touch Screen | 27" monitorResolution: 1920X1080Touch Screen | Substantially Equivalent.The added touch screen feature provided identical function/feature that had already existed on the system monitor. It cannot alter or control X-ray radiation of the system.This change did not raise any new safety and effectiveness concerns. |
| External Video Input (Picture in Picture) | N/A | Yes | Substantially Equivalent.This feature is to display the external video input on the right side of the C-arm system monitor while the |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| left side of monitor is the live image from the X-ray mobile C-arm system. This feature makes user more convenient to view the images from other devices such as endoscope etc.It functions in the same way as the cleared device OEC Elite (K172550).This change did not raise any new safety and effectiveness concerns. | |||
| Image Stitching | N/A | Yes | Substantially Equivalent.Image Stitching is to create a composite view from multiple image acquisitions to aid in surgical procedures of the spine, long bone, or pelvis.The verification and validation test to meet design inputs and user needs for this feature have been tested and the result was passed.This change did not raise any new safety and effectiveness concerns. |
| Trajectory Pointer | N/A | Yes | Substantially Equivalent.Trajectory Pointer is a feature utilizing deep learning technology to segment the Kirschner-wire then utilize a traditional algorithm to present a visual guideline to aid in positioning Kirschner-wires or similar straight, solid metallic devices. |
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GE Healthcare
510(k) Premarket Notification Submission – OEC One CFD
| Predicate DeviceOEC One ASD (K240828) | Subjected DeviceOEC One CFD | Discussion of Differences | |
|---|---|---|---|
| The verification and validation test to meet design inputs and user needs for this feature have been tested and the result was passed.This change did not raise any new safety and effectiveness concerns. |
The system continues to meet all applicable IEC 60601-1 series of standards, NEMA XR-27, and applicable parts of 21CFR Subchapter J. The changes and differences described above did not require clinical data in order to establish safety or efficacy.
The changes described above do not change the control mechanism, operating principle, energy type, or the scientific technology of the predicate devices.
Determination of Substantial Equivalence:
GE HealthCare believes the OEC One CFD is of comparable type and substantially equivalent to the cleared predicate OEC One ASD.
Non-Clinical Performance Testing
The verification and validation testing has been successfully completed as required by design control procedures under GE HealthCare's quality system. The system has been tested and is compliant with the following FDA-recognized consensus standards and FDA guidance documents:
FDA-recognized consensus standards
- IEC 60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. FDA recognition number 19-49.
- ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]. FDA recognition number 19-36.
- IEC 60601-1-3 Edition 2.2 2021-01 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. FDA recognition number 12-336.
- IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. FDA recognition number 5-132.
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510(k) Premarket Notification Submission – OEC One CFD
- IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. FDA recognition number 12-309.
- IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. FDA recognition number 12-348.
- IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures. FDA recognition number 12-351.
- IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes. FDA recognition number 13-79.
- IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices. FDA recognition number 5-129.
FDA guidance
- Pediatric information for X-ray imaging device premarket notifications, Nov 28, 2017
- Content of Premarket Submissions for Device Software Functions, June 14, 2023
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, June 27, 2025
- Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff, Aug 14, 2013
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff, Sep 01, 2016
All applicable 21CFR Subchapter J performance standards are met. 1020.30 Diagnostic X-Ray Systems and their major components, 1020.32 Fluoroscopic equipment, 1040.10 Laser products.
The OEC One CFD system was developed under the GE HealthCare Quality Management System, including design controls, risk management and software development life cycle processes. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Required Reviews
- Design Reviews
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The substantial equivalence was also based on a basic software documentation level.
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510(k) Premarket Notification Submission – OEC One CFD
Summary of Testing for Trajectory Pointer
Summary test results including acceptance criteria or other information supporting the appropriateness of the characterized performance are provided below.
Information about clinical subgroups and confounders present in the dataset:
- Anatomy (Limbs, Joints, Hands and feet, Spine, Others)
- K-wire Presence (Y/N)
- Intersection / Block Existence(Y/N)
- kV range (40-120)
- Existence of Other Metal Instruments or Implants(Y/N)
- K-wire Contrast (Clear outline / Saturated edge)
- Ethnicity/Country (US, China, EU /Australia, Phantoms)
- K-wire Quantity (0-10)
Test dataset:
- Test data covers the entire range of values for all confounders, thereby ensuring that the dataset is fully representative of real-world application scenarios.
- Total dataset included 3078 images, 307 were used for test dataset and the rest for training/tuning.
Demographic distribution of test dataset:
- Ethnicity/Country: US (51.1%), China (35.8%), Phantom (9.8%), EU/Australia (3.3%)
Expected performances:
- The MAAP (Minimal Acceptable Algorithm Performance) of the success rate is defined with a high accuracy: At least 95% of test dataset should have a Dice score above 0.9.
Performance demonstrated on test dataset:
- For Last Image Hold(LIH) images, success rate: 98.8% with a 95% confidence level. For Fluoroscopy images, success rate: 97.1% with a 95% confidence level.
- The success rate of both models exceeded the predefined MAAP (95%), demonstrating the algorithm performs as expected.
Information about equipment and protocols used to collect images:
- All images were collected from GE OEC Mobile C-arm devices: OEC One CFD, OEC One ASD, OEC One, OEC Elite MiniView
Information about how the reference standard was derived from the dataset:
- On each image, the contours of K-wires were manually outlined by trained annotators.
- 3 U.S. board certified radiologists check annotations to make sure the ground truth is correct.
Description of how independence of test data from training data was ensured:
- To prevent data leakage and ensure statistical independence between the training and test data sets, two specific measures were implemented:
- Similarity-based deduplication of K-wire images by comparing ground truth annotations.
- Rigorous data splitting. This approach guarantees that all K-wire instances in the test data set are unique and strictly independent from those in the training data set.
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510(k) Premarket Notification Submission – OEC One CFD
Additional performance testing for trajectory pointer feature using commercially available anthropomorphic phantoms that contain human simulated bone was performed. All tests passed the pre-defined acceptance criteria demonstrating a satisfactory quality for visual extended guideline to indicate the direction of K-wires or similar straight, solid metallic devices provided by OEC One CFD with trajectory pointer option.
Summary of Testing for Image Stitching
Testing using commercially available anthropomorphic phantoms of applicable body parts (spine, long bone, and pelvis) that contain human simulated bone was performed. All tests passed the pre-defined acceptance criteria demonstrating a satisfactory quality for stitched images provided by OEC One CFD with image stitching option.
Overall Image Performance Testing
Overall image performance testing was performed using commercially available anthropomorphic phantoms of representative body parts that contain human simulated bone and vascular to demonstrate that fluoroscopic anatomical images are quality images. Additional engineering testing was performed to substantiate the performance claims related to dose and image quality. In addition, sample clinical images were evaluated to demonstrate substantial equivalence for the OEC One CFD with Image Stitching and Trajectory Pointer options to the cleared predicate device.
Substantial Equivalence Conclusion
OEC One CFD follows the same design control process and software development lifecycle processes as the predicate OEC One ASD (K240828). It is substantially equivalent to the cleared predicate OEC One ASD. The indication for use is identical and has equivalent/identical technological characteristics. This type of premarket notification supports using scientific, established, engineering-based performance testing. The system has been fully tested/evaluated by using engineering bench testing. The differences discussed in this section do not introduce any adverse effects nor raise new questions of safety and effectiveness. Based on the successful verification and validation testing, additional performance bench testing, reader study results, conformance to standards, and development under the GE HealthCare Quality Management System, we believe that OEC One CFD is substantially equivalent to the cleared predicate device OEC One ASD (K240828) and therefore, is safe and effective for its intended use.
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N/A