Who is the manufacturer of Ziehm Vision RFD?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Vision RFD (K203428).

What is the FDA product code for Ziehm Vision RFD?

JAA. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Ziehm Vision RFD?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Ziehm Vision RFD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ziehm Vision RFD

K203428 · Ziehm Imaging GmbH · JAA · Mar 17, 2021 · Radiology

Device Facts

Record ID	K203428
Device Name	Ziehm Vision RFD
Applicant	Ziehm Imaging GmbH
Product Code	JAA · Radiology
Decision Date	Mar 17, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome. 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.

Device Story

Mobile fluoroscopic C-arm system; utilizes X-ray generator, C-profile stand, and flat panel detector (FPD) to capture real-time fluoroscopic, cine, and DSA images. Operated by clinicians in OR, clinic, or emergency settings via control interfaces (Vision Center/Remote Vision Center). Features motorized axes for variable iso-centric positioning and distance control for patient safety. System includes monitor cart for image processing, recording, and DICOM networking. Provides high-resolution visualization of anatomy, implants, and pathology to guide interventional/surgical procedures. Benefits include improved geometric accuracy, reduced radiation dose options, and enhanced vessel visualization. Supports computer-aided surgery workflows.

Clinical Evidence

Bench testing only. Non-clinical imaging and dose testing performed using anthropomorphic (PMMA) and anatomical simulation phantoms representing adult and pediatric populations. Radiologist assessment of image sets confirmed image quality is comparable to the predicate device. Compliance with IEC 60601-1, 60601-1-2, 60601-2-43, 60601-2-54, and 21 CFR 1020.30-32 verified.

Technological Characteristics

Mobile C-arm; 30 kW X-ray generator; rotating anode X-ray tube; aSi or CMOS flat panel detectors with CsI scintillator; asymmetrical collimator; active cooling; laser positioning (Class 2M, 635 nm). Connectivity: DICOM 3.0, wired/wireless network, video transmission. Software: DICOM-compliant image processing, dose reporting (RDSR). Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, IEC 60825-1.

Indications for Use

Indicated for adult and pediatric populations requiring intra-operative fluoroscopic, cine, and digital subtraction angiography (DSA) imaging during diagnostic, interventional, and surgical procedures (e.g., cardiology, orthopedics, neurosurgery, urology). Contraindicated for mammography and use near MRI systems.

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

Ziehm Vision RFD (K132904)

Related Devices

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K083545 — ZIEHM VISION RFD · Ziehm Imaging, Inc. · May 15, 2009
K203504 — Cios Flow · Siemens Medical Solutions USA, Inc. · Dec 22, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ March 17, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font size than the rest of the text. Ziehm Imaging GmbH % Mr. Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N. 82nd Street SCOTTSDALE AZ 85260 ## Re: K203428 Trade/Device Name: Ziehm Vision RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB, OXO Dated: February 15, 2020 Received: February 24, 2020 Dear Mr. Seeman: 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 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 located 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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203428 Device Name Ziehm Vision RFD #### Indications for Use (Describe) The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome. 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) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized representation of a human figure within a circular design, and the text is in a teal color. K203428 U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center –W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 March 11, 2020 In accordance with 21 CFR §807.92 the following 510(k) summary information is provided: | Submitter Address: | Ziehm Imaging GmbH Lina-Ammon-Strasse 10 90471 Nuremberg Germany Phone: + 49.911.2172-219 Fax: +49.911.2172-390 | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact Person Agent: | Steve Seeman Director of Requlatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N 82nd St Scottsdale AZ, 85260 | | Secondary Contact Person: | Stefan Fiedler Director QM/RA Ziehm Imaging GmbH Phone: + 49.911. 2172-219 Fax: +49.911.2172-390 | | Device (Trade Name): | Ziehm Vision RFD | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Regulation: | 21CFR 892.1650 | | Requlation Description: | Image-intensified fluoroscopic x-ray system | | Product Code: | JAA; OWB; OXO | | Classification: | II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized representation of a person inside a sphere with orbital lines around it. The text is in a teal color. | Predicate Device: | K132904 - Ziehm Vision RFD | |---------------------------------|---------------------------------------------| | Decision Date: | 12/05/2013 | | Regulation: | 21CFR 892.1650 | | Regulation Description Name: | Image-intensified fluoroscopic x-ray system | | Product Code: | JAA; OWB; OXO | General Description: The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes. > The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD). > Motorization of vertical axis as well as manual or optionally motorized three axes provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center. > The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. > The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone. > The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The text is in a teal color. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces. - Intended Use The Ziehm Vision RFD is a mobile C-arm providing image data by means of a non-invasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision RFD is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD is intended for use to provide image data specifically but not limited in the field of interventional radiology and cardiology as well as in cardiac surgery and in hybrid applications. The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system is intended for use with human bodies covering such structures but not limited to the following, e.g. orqans, tissue, bones, implants depending on the medical indication. These devices are not intended for use in performing mammographic exposures. The systems are not intended for use near MRI systems. - The Ziehm Vision RFD is intended for use in providing medical imaging for Indications for Use: adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome. 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. The proposed modified device Ziehm Vision RFD C-arm employs the same Technology: fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K132904). > The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Vision RFD C-arm (K132904). > Software architecture design is nearly identical to that of the predicate {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a globe with a human figure inside. The text is in a teal color and appears to be a sans-serif font. device Ziehm Vision RFD C-arm (K132904). With modification of the software to support functionality, image processing applications related to the optional device specific features. The primary modifications of the C-Arm include a 30 kW generator using the same housinq, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD (K132904), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, , Enhanced Vessel Visualization, measurement function, while keeping the same profile of our predicate device Ziehm Vision RFD C-arm (K132904). Summary of Technological Characteristics: The comparisons of the predicate devices show the scientific and technology characteristics of the Ziehm Vision RFD are substantial equivalence to that of the predicate device Ziehm Vision RFD (K132904). ## Device Comparison Table The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K132904) | Comparable Properties Substantial Equivalence Discussion | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Unknown at this time | K132904 | - | | Classification | Class II | Class II | Identical | | Product Code | JAA (system, x-ray, fluoroscopic, image- intensified) | JAA (system, x-ray, fluoroscopic, image- intensified) | Identical | | Application / Indications for Use | | | | | Indications for Use | The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast | The Ziehm Vision RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include | Substantially Equivalent | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K132904) | Comparable Properties Substantial Equivalence Discussion | | | density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome. | but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures, and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. | | | | 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. | 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. | | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K132904) | Comparable Properties Substantial Equivalence Discussion | | X-ray Generator | | | | | Maximum Parameter | • Variant 20 kW: max. 20 kW, max. 120 kV, max. 200 mA | • Variant 7.5 kW: max. 7.5 kW, max. 120 kV, max. 75 mA | The new proposed device generator (variant 30 kW) has a higher maximum power output. | | | • Variant 25 kW: max. 25 kW, max. 120 kV, max. 250 mA | • Variant 20 kW: max. 20 kW, max. 120 kV, max. 200 mA | 100 kV @ 300 mA. | | | • Variant 30 kW: max. 30 kW @ nominal 100kV max. 120 kV, max. 300 mA | • Variant 25 kW: max. 25 kW, max. 120 kV, max. 250 mA | | | Pulsed Fluoroscopy: Operating values | • Variant 20 kW kV range: 40 - 120 kV mA range: 1.5 - 200 mA_ | • Variant 7.5 kW kV range: 40 - 120 kV mA range: 1.5 - 75 mA_ | The new generator 30 kW of the new modified proposed device has a | | | • Variant 25 kW kV range: 40 - 120 kV mA range: 1.5 - 250 mA | • Variant 20 kW kV range: 40 - 120 kV mA range: 1.5 - 200 mA | higher maximum power output as compared to the Predicate. However, the design and housing are identical. | | | • Variant 30 kW kV range: 40 - 120 kV mA range: 1.5 – 300 mA | • Variant 25 kW kV range: 40 - 120 kV mA range: 1.5 - 250 mA_ | | | Pulsed Fluoroscopy: Pulse and Duration | • pulse width: - 20 kW generator: 7 - 40 ms | • pulse width: - 7.5 kW generator: 7 - 40 ms | | | | - 25 kW generator: 7 - 40 ms | - 20 kW generator: 7 - 40 ms | | | | - 30 kW generator: 4 - 40 ms | - 25 kW generator: 7 - 40 ms | | | | pulse rate: 50/60 Hz: 1, 2, 4, 8, 12.5, 25 pulse/s | pulse rate: 50/60 Hz: 1, 2, 4, 8, 12.5, 25 pulse/s | | | Digital Radiography (Snapshot) / Operating Values | • Variant 20kW kV range: 40 - 120 kV mA range: up to 200 mA_ | • Variant 7.5 kW kV range: 40 - 120 kV mA range: up to 75 mA_ | Although the modified device Ziehm Vision RFD is not identical to the predicate K132904 the general system exposure | | | • Variant 25kW | • Variant 20 kW | control technology and | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K132904) | Comparable Properties Substantial Equivalence Discussion | | | kV range: 40 - 120 kV mA range: up to 250 mA | kV range: 40 - 120 kV mA range: up to 200 mA | operational functionality are identical in regards to the predicate K132904 | | | Variant 30 kW kV range: 40 - 120 kV mA range: up to 300 mA | Variant 25kW kV range: 40 - 120 kV mA range: up to 250 mA | | | Thermal Management | Active cooling | Active cooling…