(99 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using traditional imaging technology and controls.
No.
The device is described as providing medical imaging for diagnostic, interventional, and surgical procedures by visualizing anatomical structures, not for treating any condition.
Yes
The device provides imaging that helps to localize regions of pathology, which is a diagnostic function.
No
The device description clearly outlines hardware components such as a mobile stand, C-Profile support, mono-block high voltage generator assembly, Flat Panel image receptor, user touch screen, and high-resolution flat panel display monitors. While software is mentioned as being substantially equivalent to the predicate, the device is fundamentally a hardware system with integrated software for control and imaging.
Based on the provided information, the Ziehm Vision FD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing medical imaging of patients during diagnostic, interventional, and surgical procedures. This involves imaging the patient's internal structures directly.
- Device Description: The description details a mobile fluoroscopy system that uses X-rays to create images of the patient's anatomy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological or pathological state. The Ziehm Vision FD does not perform this function. It images the patient directly.
Therefore, the Ziehm Vision FD is a medical imaging device, specifically a fluoroscopy system, and not an IVD.
N/A
Intended Use / Indications for Use
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic. urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
The system is not intended for use near MRI systems.
Product codes
OWB, JAA
Device Description
The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. Tehse attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient's anatomy. This visualization helps to localize reqions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and Dice and wireless network interfaces.
The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehn Vision FD (K240020). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision FD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pulsed and continuous fluoroscopic imaging
Anatomical Site
complex anatomical structures (such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic)
Indicated Patient Age Range
general populations
Intended User / Care Setting
diagnostic, interventional and surgical procedures; critical care, emergency room procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench testing included non-clinical testing methods specific to "Guidance for submission of 510(k)s for Solid State X-Ray lmaging Devices (Guidance for Industry and Drug Administration Staff, September 2016)", demonstrating system, and imaging performance. In particular physical characteristics as well as operational and exposure characteristics and safety features were taken into consideration. All requirements related to labelling and quality assurance were addressed.
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison of image quality with the predicate system. Furthernore Ziehm Imaging GmbH performed pediatic dose testing as required by FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications (Guidance for Industry and Food and Druq Administration Staff, November 2017". Anthropomorphic phantoms were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the optimized system settings (including 2k inaging chain) of the modified device shows that the image quality acquired with the test device is better or at least all images generated by the test device show more detectability and are sharper than the corresponding reference inages. From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use. Regarding imaging with pediatric dose settings the image quality may be reduced due to physical factors, but sufficient image quality is still provided to support the physician during the whole clinical procedure.
Software and cybersecurity testing was performed as required by "Content of Premarket Submissions for Device Software Functions (Guidance for Industry and Food and Drug Administration Staff, June 2023)" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Guidance for Industry and Food and Drug Administration Staff, September 2023)".
Cybersecurity testing comprises vylnerability scanning, penetration testing an static code analysis. Vulnerability scanning has been performed on the devices SBOMs and additionally using Tenable Nessus. The findings have been assessed and found acceptable. Two separate penetration tests have been conducted and displayed a qood cybersecurity posture of the results from the static code analysis indicate some code locations that might benefit from a code adaption, but no stability nor any security issue could be identified that would require immediate action. The points for insequent software releases. Overall the testing activities demonstrate a good level of cybersecurity for the device, complying with the FDA requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 13, 2025
Ziehm Imaging GmbH % Cornelia Schildbach Specialist Regulatory Affairs Lina-Ammon-Strasse 10 NUREMBERG, 90471 GERMANY
Re: K243735
Trade/Device Name: Ziehm Vision FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA Dated: December 19, 2024 Received: December 19, 2024
Dear Cornelia Schildbach:
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.
1
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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory
2
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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Ziehm Vision FD
Indications for Use (Describe)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic. urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
The system is not intended for use near MRI systems.
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 PRAStaff(@fda.hhs.gov
"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."
4
| 510(k) #: K243735 | 510(k) Summary | Prepared on: 2025-02-24 |
|---|---|---|
| ------------------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Ziehm Imaging GmbH |
| Applicant Address | Lina-Ammon-Strasse 10 Nuremberg 90471 Germany |
| Applicant Contact Telephone | 49 (91166) 067-258 |
| Applicant Contact | Mrs. Cornelia Schildbach |
| Applicant Contact Email | Zie-Regulatory@ziehm.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | Ziehm Vision FD |
| Common Name | Interventional Fluoroscopic X-Ray System |
| Classification Name | Image-intensified fluoroscopic x-ray system |
| Regulation Number | 892.1650 |
| Product Code(s) | OWB, JAA |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K240020 | Ziehm Vision FD | OWB |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. Tehse attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient's anatomy. This visualization helps to localize reqions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and Dice and wireless network interfaces.
The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehn Vision FD (K240020). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision FD.
Intended Use/Indications for Use
21 CFR 807 92(a)(5)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures such as vascular cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, enom procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.
5
Indications for Use Comparison
The indications for use of the predicate and modified device are equivalent.
Technological Comparison
The key modification refers to an software update to software version 7.10.0, which incorporates the 2k imaging chain "QuantumStream", along with the corresponding new "Image Insights" overlay. In addition to the already introduced 8 inch IGZO flat panel detector (K231700), the modified Ziehm Vision FD offers an additional IGZO panel. The manufacturing technology (IGZO, Indium-Gallium-Zinc-Oxide) of both detectors, the detector size as well as the image quality are equivalent.
The predicate Ziehm Vision FD (K240020) and the modified Ziehm Vision FD share substantially equivalent design, technology, functionality and have substantially equivalent Indications for Use.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The design of the modified Ziehm Vision FD was completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls, 21 CFR 820 and applicable standards. Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the following text.
The modified Ziehm Vision FD complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant safety standards such as ANSI AAM E560601-1-2:2020, IEC 60601-1-3:2021, IEC 60601-243:2022 and IEC 60601-2-54:2022.
Performance bench testing included non-clinical testing methods specific to "Guidance for submission of 510(k)s for Solid State X-Ray lmaging Devices (Guidance for Industry and Drug Administration Staff, September 2016)", demonstrating system, and imaging performance. In particular physical characteristics as well as operational and exposure characteristics and safety features were taken into consideration. All requirements related to labelling and quality assurance were addressed.
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison of image quality with the predicate system. Furthernore Ziehm Imaging GmbH performed pediatic dose testing as required by FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications (Guidance for Industry and Food and Druq Administration Staff, November 2017". Anthropomorphic phantoms were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the optimized system settings (including 2k inaging chain) of the modified device shows that the image quality acquired with the test device is better or at least all images generated by the test device show more detectability and are sharper than the corresponding reference inages. From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use. Regarding imaging with pediatric dose settings the image quality may be reduced due to physical factors, but sufficient image quality is still provided to support the physician during the whole clinical procedure.
Software and cybersecurity testing was performed as required by "Content of Premarket Submissions for Device Software Functions (Guidance for Industry and Food and Drug Administration Staff, June 2023)" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Guidance for Industry and Food and Drug Administration Staff, September 2023)".
Cybersecurity testing comprises vylnerability scanning, penetration testing an static code analysis. Vulnerability scanning has been performed on the devices SBOMs and additionally using Tenable Nessus. The findings have been assessed and found acceptable. Two separate penetration tests have been conducted and displayed a qood cybersecurity posture of the results from the static code analysis indicate some code locations that might benefit from a code adaption, but no stability nor any security issue could be identified that would require immediate action. The points for insequent software releases. Overall the testing activities demonstrate a good level of cybersecurity for the device, complying with the FDA requirements.
After review of the modified device Ziehn Vision FD risk control assessment, the verification activities which successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended use, and performs as designed and raises no new questions regarding either safety or effectiveness. Ziehm Imaging GmbH therefore believes the modified device Ziehm Vision FD to be substantial equivalent to the predicate device Ziehm Vision FD (K240020).
21 CFR 807 92(a)(5)
21 CFR 807.92(a)(6)