Who is the manufacturer of Ziehm Vision RFD 3D?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Vision RFD 3D (K202360).

What is the FDA product code for Ziehm Vision RFD 3D?

OWB. 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 3D?

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

Who can help prepare an FDA 510(k) submission like Ziehm Vision RFD 3D?

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 3D

K202360 · Ziehm Imaging GmbH · OWB · Sep 16, 2020 · Radiology

Device Facts

Record ID	K202360
Device Name	Ziehm Vision RFD 3D
Applicant	Ziehm Imaging GmbH
Product Code	OWB · Radiology
Decision Date	Sep 16, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinical outcome. 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.

Device Story

Mobile C-arm fluoroscopic X-ray system; consists of mobile stand (C-arm) and monitor cart. Inputs: X-ray signals captured by flat panel detector (FPD). Operation: Physician-controlled X-ray generator produces radiation; motorized 4-axis C-profile allows variable iso-centric positioning. 3D imaging uses iterative algorithm to compute 3D volumes from scan images. Outputs: 2D fluoroscopic/cine/DSA images and 3D reconstructions (MPR, volume rendering, surface rendering) displayed on LCD monitors. Used in OR/clinic by physicians/technicians. Distance control surface detection slows motorized movement near objects. Output assists in localizing pathology, guiding surgical procedures, and computer-assisted surgery. Benefits: intra-operative visualization of complex anatomy, reduced radiation dose options, and improved workflow.

Clinical Evidence

No clinical data. Bench testing only. Included electrical safety (ANSI/AAMI ES60601-1), EMC (IEC 60601-1-2), and performance testing (21 CFR 1020.30-32). Image quality and dose performance validated using anthropomorphic (PMMA) and anatomical simulation phantoms representing adult and pediatric populations. Radiologist assessment confirmed image quality comparable to predicate.

Technological Characteristics

Mobile C-arm with 30 kW mono-block X-ray generator, rotating anode tube, and flat panel detector (aSi or CMOS). 4-axis motorized movement. Connectivity: DICOM 3, wired/wireless network, USB/DVD storage. Software: iterative 3D reconstruction algorithm. Safety: Distance control surface detection, laser positioning (Class 2M, 635 nm). Power: 100-240 VAC. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for adult and pediatric patients requiring 2D and 3D pulsed and continuous fluoroscopic imaging during diagnostic, interventional, and surgical procedures (e.g., cardiology, orthopedics, neurology, trauma, maxillofacial). Not for mammography or 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 3D (K142740)

Related Devices

K142740 — Ziehm Vision RFD 3D · Ziehm Imaging GmbH · Apr 6, 2015
K073346 — ZIEHM VISION 2 · Ziehm Imaging, Inc. · Mar 21, 2008
K202547 — Surgivisio system · Surgivisio · Mar 26, 2021
K061310 — ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM · Ziehm Imaging, Inc. · Jul 7, 2006
K220627 — SURGIVISIO Device · Ecential Robotics · Mar 18, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ September 16, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Ziehm Imaging GmbH % Mr. Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm-Orthoscan, Inc. 14555 N. 82nd Street SCOTTSDALE AZ 85260 # Re: K202360 Trade/Device Name: Ziehm Vision RFD 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAK, JAA, OXO Dated: August 14, 2020 Received: August 19, 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 (OS) 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 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-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) K202360 Device Name Ziehm Vision RFD 3D #### Indications for Use (Describe) The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinical outcome. 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. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with intersecting lines, resembling a globe with a human figure inside. To the right of the graphic is the text "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company. 510(k) Number: K202360 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 September 15, 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 Regulatory 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 3D | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Classification(s) | 21CFR 892.1650 | | Classification Names: | Image-intensified fluoroscopic x-ray system | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and appears to be slightly faded. Device: Interventional fluoroscopic x-ray system OWB, JAK, JAA, OXO Product Code: Predicate Device: K142740 Ziehm Vision RFD 3D Decision Date: 04/06/2015 21CFR 892.1650 Classification: Classification Image-intensified fluoroscopic x-ray system Names: Interventional fluoroscopic x-ray system Device: Product Code: OWB, JAA, JAK, OXO General Description: The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray tube in the generator produces X-rays, 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 3D 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). > The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font. 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. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions. 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. 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, 2D image processing, Optional 3D 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 3D 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 3D is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD 3D is intended for use to provide 2D and 3D image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Furthermore, it is intended for use specifically but not limited to the imaging of soft tissues. 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 as structures but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication. The system is not intended for use near MRI systems or for mammography. {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 text is in a teal color and appears to be a sans-serif font. The circular graphic contains a stylized image of a person inside of a globe. The Ziehm Vision RFD 3D system is intended for use in providing both 2D and Indications for Use: 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and Carm positioning data is required for Computer-Assisted Surgery procedures. 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 3D C-arm employs Technology: the same fundamental control, and scientific technology as that of our predicate device Ziehm Vision RFD 3D C-arm (K142740). 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 3D C-arm (K142740). Software architecture design is nearly identical to that of the predicate device Ziehm Vision RFD C-arm (K142740). With modification of the software to support functionality, Imaqe processing applications related to the optional device specific features. The primary modifications of the C-Arm include a 30 kW generator using the same housing, x-ray tube, and very similar design while keeping the same dimensions as the predicate Ziehm Vision RFD 3D (K142740), new pre-filter and low absorption removable grid, for lower skin entrance dose imaging, improving operator workflow during extended procedures, brachytherapy geometric data, updated NaviPort, enhanced vessel visualization, enhanced screw visualization, surface rendering, measurement function, while keeping {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, along with the company name "ziehmimaging" in a teal sans-serif font. The logo appears to be for a medical imaging company. the same profile of our predicate device Ziehm Vision RFD 3D C-arm (K142740). Summary of The comparisons of the predicate devices show the scientific and Technological technology characteristics of the Ziehm Vision RFD 3D are substantial equivalence to that of the predicate device Ziehm Vision Characteristics: RFD 3D (K142740). #### Device Comparison Table | Model | Modified Ziehm Vision RFD 3D | Predicate Ziehm Vision RFD3D (K142740) | Comparable Properties Substantial Equivalence Discussion | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Unknown at this time | K142740 | - | | Classification | Class II | Class II | Identical | | Product Code | OWB (interventional fluoroscopic x-ray system) | OWB (interventional fluoroscopic x-ray system) | Identical | | Application / Indications for Use | | | | | Indications for Use | The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations. The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 | The ZIEHM VISION RFD 3D is intended for use in providing both 2D and 3D medical imaging for all 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, | Removed the following statement from the proposed device in the IFU (At the discretion of a physician the device may be used for other imaging applications). | | Model | Modified Ziehm Vision RFD 3D | Predicate Ziehm Vision RFD3D (K142740) | Comparable Properties Substantial Equivalence Discussion | | | 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 lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer- Assisted Surgery procedures. The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C- arm positioning data is | 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 lumbar 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 variable iso- centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures and a 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. | | | Model | Modified Ziehm Vision RFD 3D | Predicate Ziehm Vision RFD3D (K142740) | Comparable Properties Substantial Equivalence Discussion | | | required for Computer- Assisted Surgery procedures. 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. | 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. | | | X-ray Generator | | | | | Maximum Parameter | • Variant A0: max. 25 kW, max. 120 kV, max. 250 mA Variant A1: max. 30 kW @ nominal 100kV max. 120 kV, max. 300 mA | Variant A2: max. 25 kW, @ nominal 100kV max. 120 kV, max. 250 mA | Predicate The new proposed device generator (variant 30 kW) has a higher maximum power output. 100 kV @ 300 mA. | | Pulsed Fluoroscopy: Operating values | • Variant A0:25 kW kV range: 40 - 120 kV mA range: 0.2 - 250 mA Variant A1: 30 kW kV range: 40 - 120 kV mA range: 0.2 - 300 mA | • Variant A2:25 kW kV range: 40 - 120 kV mA range: 0.2 - 250 mA | The new generator (variant A1) of the new modified proposed device has a higher maximum power output as compared to the Predicate. however, the design and housing are identical. | | Model | Modified Ziehm Vision RFD 3D | Predicate Ziehm Vision RFD3D (K142740) | Comparable Properties Substantial Equivalence Discussion | | Pulsed Fluoroscopy: Pulse and Duration | • pulse width: 4 - 40 ms (30cm and 31 cm" FPD aSi/CMOS) pulse rate: 50/60 Hz: 1, 2, 4, 8, 12.5, 25 pulse/s | • pulse width: 4 - 40 ms (30cm and 31 cm" FPD aSi/CMOS) pulse rate: 50/60 Hz: 1, 2, 4, 8, 12.5, 25 pulse/s | Identical. | | Digital Radiography (Snapshot) / Operating Values | • Variant A0: 25kW kV range: 40 - 120 kV mA range: up to 250 mA • Variant A1: 30 kW kV range: 40 -120 kV mA range: up to 300 mA with Varex 31 cm CMOS FPD, and Varex 30 cm aSi FPD) | • Variant A2: 25kW kV range: 40 - 120 kV mA range: up to 250 mA | Although the modified device Ziehm Vision RFD 3D is not identical to the predicate K142740 the general system exposure control technology and operational functionality are identical in regards to the predicate K142740 | | Thermal Management | Active cooling: | Active cooling: | Identical | | X-ray Tube | | | | | Tube Type | Rotating anode: | Rotating anode: | Identical | | Beam Limiter/ Collimator | | | | | Collimator System | Digital Collimator: | Asymmetrical Collimator: | Identical in operation. Name change | | Image Detector | |…