Who is the manufacturer of Ziehm Vision RFD?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Vision RFD (K231692).

What is the FDA product code for Ziehm Vision RFD?

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?

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

K231692 · Ziehm Imaging GmbH · OWB · Nov 20, 2023 · Radiology

Device Facts

Record ID	K231692
Device Name	Ziehm Vision RFD
Applicant	Ziehm Imaging GmbH
Product Code	OWB · Radiology
Decision Date	Nov 20, 2023
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 intraoperative 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, 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 consisting of a mobile stand (C-arm with X-ray generator and flat panel detector) and a monitor cart/workstation. Captures X-ray images for real-time visualization during interventional and surgical procedures. Operated by physicians/clinicians in ORs, clinics, or emergency settings. Transforms X-ray inputs into digital images displayed on integrated LCD monitors. Supports digital subtraction angiography (DSA) and cine capture. Provides high-resolution anatomical visualization to assist in localization of pathology, surgical guidance, and assessment of clinical outcomes. Benefits patients by enabling minimally invasive procedures through precise intraoperative imaging. Includes optional wireless footswitch and various network interfaces for DICOM image storage and peripheral connectivity.

Clinical Evidence

Bench testing only. Non-clinical image comparison and dose testing were performed using anatomical simulation phantoms representative of adult and pediatric populations. A radiologist assessed image sets, concluding that image quality is comparable to the predicate device. Compliance with electrical safety (ANSI/AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and X-ray performance standards (21 CFR 1020.30-32) was demonstrated.

Technological Characteristics

Mobile C-arm X-ray system. Detectors: 8-inch/12-inch a-Si, CMOS, and new 12-inch IGZO flat panel detectors with Cesium-Iodide (CsI) scintillators. Generator: 20kW, 25kW, or 30kW mono-block. Connectivity: DICOM wired/wireless, USB, DVD. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54. Software: Application-Oriented Anatomical Programs (AOAP) and Anatomical Marking Tool (AMT).

Indications for Use

Indicated for adult and pediatric populations requiring fluoroscopic, cine, and digital subtraction angiography (DSA) imaging during diagnostic, interventional, and surgical procedures (e.g., cardiology, orthopedics, neurosurgery, urology, emergency care). 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 (K203428)

Related Devices

K234109 — Ziehm Solo FD · Ziehm Imaging GmbH · Jan 26, 2024
K203428 — Ziehm Vision RFD · Ziehm Imaging GmbH · Mar 17, 2021
K243328 — Ziehm Vision RFD · Ziehm Imaging GmbH · Jan 15, 2025
K203504 — Cios Flow · Siemens Medical Solutions USA, Inc. · Dec 22, 2020
K982706 — PHILIPS BV300 SERIES RELEASE 2.1 · Philips Medical Systems, Inc. · Sep 2, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ November 20, 2023 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, which consists of 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. Ziehm Imaging GmbH % Stefan Fiedler Director Quality Management & Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY Re: K231692 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: October 23, 2023 Received: October 23, 2023 Dear Stefan Fiedler: 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. 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). {1}------------------------------------------------ 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. 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 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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K231692 Device Name Ziehm Vision RFD ## Indications for Use (Describe) 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 intraoperative 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, 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) ver-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 on the left and the company name "ziehmimaging" on the right. The text is in a teal color, with the "imaging" portion being a darker shade of teal. 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 K231692 November 20, 2023 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 66067 0 Fax: +49 911 66067 390 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Primary Contact Person Agent: | Kevin Bridgman VP Quality Assurance & Requlatory Affairs Ziehm-Orthoscan, Inc. 14555 N 82nd St Scottsdale AZ, 85260 | | Secondary Contact Person: | Stefan Fiedler Director QM/RA Ziehm Imaging GmbH Phone: +49 911 66067 219 Fax: +49 172 8651712 | | Device (Trade Name): | Ziehm Vision RFD | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Regulation: | 21CFR 892.1650 | | Regulation 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 Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic features a stylized human figure inside a globe-like structure. The text is in a teal color and appears to be a sans-serif font. | Predicate Device: | K203428 - Ziehm Vision RFD | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Decision Date: | 03/17/2021 | | Regulation: | 21CFR 892.1650 | | Regulation Description Name: | Image-intensified fluoroscopic x-ray system | | Product Code: | JAA; OWB; OXO | | Summary of Technological Characteristics | The Ziehm Vision RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X- rays, guided 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 (EPD) and fluoroscopic X-ray imaging system consisting of two mobile units. | at panel detector (FPD) 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 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, 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. The proposed modified device Ziehm Vision RFD C-arm employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K203428). The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are the same as the predicate device Ziehm Vision RFD C-arm (K203428). Software architecture design is substantially equivalent to that of the predicate device Ziehm Vision RFD C-arm (K203428). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font, with the letters gradually becoming darker from left to right. The primary modification of the C-Arm includes a 12 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) which have substantially equivalent technology characteristics as our predicate device Ziehm Vision RFD C-arm (K203428). The new 12 inch IGZO FPD is an addition to already introduced a-Si and CMOS FPD's. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8inch and 12 inch aSi, 8 inch and 12 inch CMOS and the only difference to the predicate Ziehm Vision RFD is the new 12 inch IGZO panel. The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision RFD are substantially equivalent as those of the Ziehm Vision RFD predicate device (K203428). - 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.q. organs, 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. - 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 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 in all MRI environments. {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. ## 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 (K203428) | Comparable Properties Substantial Equivalence Discussion | |--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K231692 | K203428 | - | | 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 density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional | 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 | Identical | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K203428) | Comparable Properties Substantial Equivalence Discussion | | | 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 in all MRI environments. | 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. | | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K203428) | Comparable Properties Substantial Equivalence Discussion | | Digital Radiography (Snapshot) / Operating Values | • Variant 20kW kV range: 40 - 120 kV mA range: up to 200 mA • Variant 25kW kV range: 40 - 120 kV mA range: up to 250 mA • Variant 30 kW kV range: 40 - 120 kV mA range: up to 300 mA | • Variant 20kW kV range: 40 - 120 kV mA range: up to 200 mA • Variant 25kW kV range: 40 - 120 kV mA range: up to 250 mA • Variant 30 kW kV range: 40 - 120 kV mA range: up to 300 mA | Identical | | Beam Limiter/ Collimator | | | | | Collimator System | Asymmetrical Collimator: • Devices with 12inch and 8inch cm Flat Panel Detectors: • Dedicated pre- collimator for FPD • Collimator Rotation: +/- 90° • Iris and Asymmetric SlotCollimator: - 50 - 307 mm diameter (12 inch FPD CMOS & IGZO) -50 - 298 mm diameter (12 inch FPD aSi) - 50-205 mm diameter (8inch FPD CMOS) • Virtual Collimation without radiation | Asymmetrical Collimator: • Devices with 12inch and 8inch cm Flat Panel Detectors: • Dedicated pre- collimator for FPD • Collimator Rotation: +/- 90° • Iris and Asymmetric SlotCollimator: - 50 - 307 mm diameter (12 inch FPD CMOS) -50 - 289 mm diameter (12 inch FPD aSi) - 50-205 mm diameter (8inch FPD CMOS) - 50-198 mm diameter (8inch FPD aSi) • Virtual Collimation without radiation | The collimator system of the IGZO is the same as the already introduced CMOS FPD. | | Image Detector | | | | | Detector Technology | Variant aSi FPD: • Type: Amorphous Silicon Flat Panel Detector (aSi) • Scintillator: Cesium- Iodide (CsI) Variant CMOS FPD: | Variant aSi FPD: • Type: Amorphous Silicon Flat Panel Detector (aSi) • Scintillator: Cesium- Iodide (CsI) Variant CMOS FPD: • Type: CMOS Flat Panel | The new 12 inch IGZO (FPD) is an additional flat panel type beside the already established FPDs based on aSi (amorphous Silicon) and CMOS (Complementary Metal Semi-conductor) | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K203428) | Comparable Properties Substantial Equivalence Discussion | | | • Type: CMOS Flat Panel Detector • Scintillator: Cesium- Iodide (CsI) Variant IGZO FPD: • Type: IGZO Flat Panel Detector • Scintillator: Cesium- Iodide (CsI) | • Scintillator: Cesium_ | technology. IGZO FPDs are using the aSi/IGZO sensor technology | | Detector Sizes | 30cm x 30cm (12inch) aSi (amorphous silicon TFT technology) • Size: 29.8 cm x 29.8 cm • Detector matrix: 1,536 x 1,536 pixels • Magnifier 1: 1,024 x 1,024 pixels • Magnifier 2: 768 x 768 pixels • Scintillator cesium iodide • Dynamic Range: 94 dB • DQE: 77% • MTF>50%@1lp/mm • Pixel size 194µm • Garyscale 65,536 gray scale values (16bit) • System resolution (Nyquist): 2.6 lp/mm | 30cm x 30cm (12inch) aSi (amorphous silicon TFT technology) • Size: 29.8 cm x 29.8 cm • Detector matrix: 1,536 x 1,536 pixels • Magnifier 1: 1,024 x 1,024 pixels • Magnifier 2: 768 x 768 pixels • Scintillator cesium iodide • Dynamic Range: 94 dB • DQE: 77% • MTF>50%@1lp/mm • Pixel size 194µm • Garyscale 65,536 gray scale values (16bit) • System resolution (Nyquist): 2.6 lp/mm | The active pixel area of the detector types are not identical but are very similar in image area of approx. 12 inch x 12 inch. IGZO detector has higher number of pixel and smaller pixel pitch accordingly; therefor the IGZO detector has better resolution compared to aSi detectors. This shows the technical advantage over the established aSi systems. The slight differences in detector and pixel size does not have influence on safety and effectiveness of the C-arm. | | | Variant 31 cm x 31 cm (12inch) CMOS Technology: • Size: 30.7 cm x 30.7 cm • Detector matrix: 3,072 x 3,072 pixels • Magnifier 1: 2,048x 2,048 pixels • Magnifier 2: 1,536 x 1,536 pixels • Dynamic Range: - 1x1 binning:84 dB - 2x2 binning: 95 dB | Variant 31 cm x 31 cm (12inch) CMOS Technology: • Size: 30.7 cm x 30.7 cm • Detector matrix: 3,072 x 3,072 pixels • Magnifier 1: 2,048x 2,048 pixels • Magnifier 2: 1,536 x 1,536 pixels • Dynamic Range: - 1x1 binning:84 dB - 2x2 binning: 95 dB | | | Model | Modified Ziehm Vision RFD | Predicate Ziehm Vision RFD (K203428) | Comparable Properties Substantial Equivalence Discussion | | | • Scintillator: cesium iodide • DQE: 75% • MTF: - 1 lp/mm: 55 % - 2 lp/mm: 23 % - 3 lp/mm: 10 % - 4 lp/mm: 5 % • Pixel size 100 µm • Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist): 5 lp/mm | • Scintillator: cesium iodide • DQE: 75% • MTF: - 1 lp/mm: 55 % - 2 lp/mm: 23 % - 3 lp/mm: 10 % - 4 lp/mm: 5 % • Pixel size 100 µm • Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist): 5 lp/mm | | | | 20 cm x 20 cm (8inch) aSi (amorphous silicon TFT technology) • Size: 19.9 cm x 19.9 cm • Detector matrix: 1,024 x 1,024 pixels • Magnifier 1: 768 x 768 pixels • Magnifier 2: 512 x 512 pixels • Scintillator cesium iodide • Dynamic Range: 94 dB • DQE: 77% • MTF>50%@1lp/mm • Pixel size 194µm • Garyscale 65,536 gray scale values (16bit) • System resolution (Nyquist): 2.6 lp/mm | 20 cm x 20 cm (8inch) aSi (amorphous silicon TFT technology) • Size: 19.9 cm x 19.9 cm • Detector matrix: 1,024 x 1,024 pixels • Magnifier 1: 768 x 768 pixels • Magnifier 2: 512 x 512 pixels • Scintillator cesium iodide • Dynamic Range: 94 dB • DQE: 77% • MTF>50%@1lp/mm • Pixel size 194µm • Garyscale 65,536 gray scale values (16bit) • System resolution (Nyquist): 2.6 lp/mm | | | | Variant 21 cm x 21 cm (8inch) CMOS Technology: • Size: 20.5 cm x 20.5 cm • Detector matrix: 2,053x 2,053 pixels • Magnifier 1: 1,536 x 1,536 pixels | Variant 20.5 cm x 20.5 cm (8inch) CMOS Technology: • Size: 20.5 cm x 20.5 cm • Detector matrix: 2,048x 2,048 pixels • Magnifier 1: 1,536 x 1,536 pixels • Magnifier 2: | | | Model | Modified Ziehm Vision RFD…