Orthoscan TAU Mini C-Arm

K250587 · Ziehm-Orthoscan, Inc. · OXO · Jul 2, 2025 · Radiology

Device Facts

• Record ID: K250587
• Device Name: Orthoscan TAU Mini C-Arm
• Applicant: Ziehm-Orthoscan, Inc.
• Product Code: OXO · Radiology
• Decision Date: Jul 2, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Orthoscan TAU Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

Device Story

Mobile mini C-arm fluoroscopic X-ray system; provides real-time imaging for orthopedic/surgical procedures. Input: X-ray radiation; processed via flat panel detector and generator. Output: Fluoroscopic images displayed on workstation monitor. Used in OR, emergency, and clinic settings by physicians/technicians. Modifications include Linux OS upgrade (Ubuntu 20.04), improved generator power management, alternate radiation shielding, updated wireless footswitch protocol (code-hopping), and optional 32-inch display. System maintains identical mechanical/imaging functions as predicates. Clinicians use images for intraoperative guidance; facilitates minimally invasive procedures; improves diagnostic/surgical accuracy.

Clinical Evidence

No clinical data; bench testing only. Performance validated using anthropomorphic (PMMA) and anatomical simulation phantoms. Radiologist performed comparative assessment of image sets from subject and predicate devices. Results confirmed equivalent or slightly improved image quality at similar dose rates. Testing included system verification, software life cycle processes (IEC 62304), and electrical safety (IEC 60601-1/2-54).

Technological Characteristics

Mobile fluoroscopic X-ray system. Components: C-arm support, flat panel detector, X-ray generator, workstation. Materials: Alternate generator radiation shielding. Connectivity: DICOM wired/wireless network interfaces. Software: Linux-based (Ubuntu 20.04). Power: Generator with improved power management. Standards: IEC 60601-1 Ed 3.2, IEC 60601-2-54, IEC 62304. Wireless: Code-hopping communication protocol for footswitch.

Indications for Use

Indicated for general fluoroscopic visualization of patients of all ages, including pediatric populations, during diagnostic, surgical, and critical emergency care procedures involving limbs, extremities, and shoulders in clinical settings such as hospitals, ambulatory surgery, emergency, traumatology, orthopedic, and critical care environments.

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

• Orthoscan TAU Mini C-Arm (K213113)
• Orthoscan VERSA TAU Mini C-Arm (K243452)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 2, 2025

Ziehm-Orthoscan, Inc.
% Kevin Bridgman
VP of Regulatory Affairs and Quality Assurance
14555 N. 82nd St.
SCOTTSDALE, AZ 85260

Re: K250587
Trade/Device Name: Orthoscan TAU Mini C-Arm
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OXO, JAA, MQB
Dated: June 5, 2025
Received: June 5, 2025

Dear Kevin Bridgman:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250587 - Kevin Bridgman
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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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K250587 - Kevin Bridgman
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250587 | |
| Device Name Orthoscan TAU Mini C-Arm | |
| Indications for Use (Describe) The Orthoscan TAU Mini C-arm X-ray system is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments. | |
| 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

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510(k) Summary

510(k) Premarket Notification Submission- Ziehm-Orthoscan, Inc. TAU Mini C-Arm

Submitter: Ziehm-Orthoscan, Inc.
14555 N 82nd St.
Scottsdale, AZ 85260
Phone: [phone]
Fax: [phone]
Primary Contact: Kevin Bridgman; [e-mail]
Secondary Contact: TuAnh Ngo; [e-mail]
Date: June 30, 2025

In accordance with the requirements of 21 CFR 807.92 the following 510(k) summary of information is provided:

Device Trade Name: Orthoscan TAU Mini C-Arm
510(k) Number: K250587
Common/Usual Names: Fluoroscopic X-Ray System, Mobile Mini Mobile C-arm, Mini C-arm
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Device: Image-intensified fluoroscopic x-ray system, mobile
Product Codes: OXO, JAA, MQB

Primary Predicate: Orthoscan TAU Mini C-Arm
510(k) Number: K213113
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Product Code: OXO, JAA, MQB

Secondary Predicate: Orthoscan VERSA TAU Mini C-Arm
510(k) Number: K243452
Regulation: 21 CFR 892.1650
Device Class: Class II
Regulation Names: Image-intensified fluoroscopic x-ray system
Product Code: OXO, JAA, MQB

General Description:

The proposed modifications to Orthoscan TAU Mini C-Arm system models 1000-0015, 1000-0016, 1000-0017 retain identical function as the predicate Orthoscan TAU Mini C-Arm (K213113) and the Orthoscan VERSA Mini C-arm (K243452) as a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment and surgical procedures involving anatomical regions such as but not limited to that of extremities, limbs, shoulders and knees and hips. The system consists of C-arm support attached to the image workstation.

The changes to the Orthoscan TAU Mini C-Arm X-ray system models 1000-0015, 1000-0016, 1000-0017 represent a modification of our presently legally marketed devices Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452). The proposed modifications to the predicate encompass the implementation of a LINUX based operating system upgrade from Ubuntu version 16.04 to Ubuntu version 20.04, revisions to generator printed circuit board to improve power management efficiency, implementation of an alternate generator radiation shielding material to reduce environmental impact of lead, update to wireless footswitch communication protocol, an alternate detector for Orthoscan TAU Mini C-arm model 1000-0017 and the introduction of an optional 32in. display monitor.

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The proposed device replicates the features and functions of the predicate devices without impacting image clarity or dose levels.

For both the predicate TAU (K213113) and proposed device, the following are unchanged; C-arm support of flat panel detector, generator and x-ray controls, mechanical connections, balancing, locking, rotations, work-station platform, main user interface controls, touch screen interface, selectable imaging, X-ray technique control, entry of patient information, wired footswitch operation, interface connection panel and DICOM fixed wire and wireless network interfaces.

## Indications for Use:

The Orthoscan TAU Mini C-arm is designed to provide physicians with general fluoroscopic visualization, using pulsed or continuous fluoroscopy, of a patient including but not limited to, diagnostic, surgical, and critical emergency care procedures for patients of all ages including pediatric populations when imaging limbs/extremities, shoulders, at locations including but not limited to, hospitals, ambulatory surgery, emergency, traumatology, orthopedic, critical care, or physician office environments.

## Indications for Use Comparison:

The proposed modifications to Orthoscan TAU Mini C-Arm series do not change the indications for use. The indications for use are the same as the predicate device Orthoscan TAU (K213113) Mini C-Arms.

## Technology:

The changes to the proposed device Orthoscan TAU Mini C-arm X-ray systems represent a modification of our presently legally marketed device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA (K243452). With the introduction of a Linux based operating system (OS) upgrade from Ubuntu 16.04 to Ubuntu 20.04, an open source highly secure OS, cybersecurity controls are improved, image quality is maintained or improved, and capability is created for future expansions of the proposed Orthoscan TAU device models. Revisions to generator printed circuit board improve power management efficiency and implementation of an alternate generator radiation shielding material reduces environmental impact of lead. Updating the communication protocol of wireless footswitch from fixed pairing method to code-hopping method maintains state of the art wireless communications and perpetuates free operator movement with fewer cables in the way. Alternate detector(s) for the 1000-0017 to establish an alternate detector supply chain source for Orthoscan TAU model 1000-0017 while maintaining or improving image at same or similar dose, and the addition of an optional 32in. monitor screen provides a larger displayed image.

## Summary of Technological Characteristics:

The comparisons of the proposed modifications to Ziehm-Orthoscan, Inc. TAU Mini C-Arm demonstrate that the scientific and technology characteristics indicate substantial equivalence to the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452).

## Adverse Effects on Health:

The proposed modified Orthoscan TAU Mini C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management and controlled by meeting the applicable CDRH 21 CFR subchapter J performance requirements, Recognized Consensus Standards, designing and manufacturing under Ziehm-Orthoscan, Inc. Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable regulations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.

## Non-Clinical Testing Summary:

Verification and Validation including hazard mitigations executed resulted in demonstrated system that met Design Input and user needs. The device was tested by certified test laboratory resulting in device being certified compliant with 60601-1 ED 3.2 series, including IEC 60601-2-54, well as IEC 62304:2006 + A1:2015 Medical device software – Software life cycle processes. Further, the device met all applicable

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sections of 21 CFR Subchapter J performance standards. Additionally, software and cybersecurity testing were performed to meet requirements from the FDA guidances "Content of Premarket Submissions for Device Software Functions" (2023) and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (2023), as well as all other applicable software and cybersecurity guidances and regulations. The proposed modified Orthoscan TAU Mini C-Arm development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to;

- Risk Analysis
- Required reviews
- Design reviews
- Component testing
- Integration testing
- Performance testing
- Safety testing
- Product use testing

Performance bench testing included non-clinical testing methods specific to guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstrating system, and imaging performance. Non-clinical image and dose lab testing were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, images were taken by both the proposed TAU and the predicate device Orthoscan TAU (K213113). Numerous image comparison sets were taken, and a Radiologist performed an assessment of individual images arranged in groups of image sets. His conclusion was that the image quality at same or similar patient dose rates will result in equivalent or slight improvement in patient care (images) for the proposed modified TAU device over the predicate device. Therefore, Ziehm-Orthoscan, Inc. believes the proposed Orthoscan TAU Mini C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Orthoscan TAU (K213113) and Orthoscan VERSA Mini C-arm (K243452).

## Summary of Clinical Test Data:

Orthoscan TAU Mini C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the related guidance documents, Premarket Assessment of Pediatric Medical Devices May 24, 2014 and Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017.

Therefore, Ziehm-Orthoscan, Inc. conducted a lab test image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken in comparison to the predicate Orthoscan TAU Mini C-Arm (K213113) and VERSA (K243452). Images collected included phantom motion that was representative of typical clinical use, as judged by a Certified Radiologist.

Image quality comparisons representative of diagnostic, surgical, and critical emergency care procedures were collected. These images were reviewed by a Certified Radiologist who confirmed that the image quality acquired using the proposed alternate detector was of equal or slightly improved image quality, and that the images evaluated represented typical clinical use and fulfill the requirements stated by the intended use of the device.

## Substantial Equivalence Conclusion:

The changes and differences of the proposed Orthoscan TAU Mini C-Arm described do not change the control mechanism, operating principle, energy type, or intended use found on the predicate device Orthoscan TAU Mini C-Arm (K213113) and Orthoscan VERSA Mini C-arm (K243452).

Ziehm-Orthoscan, Inc. considers the proposed modified Orthoscan TAU Mini C-arm to be as safe, as effective, and performs substantially equivalent to the predicate device Orthoscan TAU Mini C-arm (K213113) and Orthoscan VERSA Mini C-arm (K243452) in accordance with its labeling.