Who is the manufacturer of Ziehm Vision FD?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Vision FD (K193230).

What is the FDA product code for Ziehm Vision FD?

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 FD?

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

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

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 FD

K193230 · Ziehm Imaging GmbH · OWB · Dec 20, 2019 · Radiology

Device Facts

Record ID	K193230
Device Name	Ziehm Vision FD
Applicant	Ziehm Imaging GmbH
Product Code	OWB · Radiology
Decision Date	Dec 20, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.

Device Story

Mobile fluoroscopic C-arm system for intraoperative imaging. Inputs: X-ray radiation; outputs: real-time fluoroscopic images on high-resolution flat panel displays. Operated by clinicians in OR/clinic settings. Features motorized vertical movement, manual C-arm positioning, and touch-screen interface for technique control. Includes ZAIP (Ziehm Adaptive Image Processing) for noise filtering and edge enhancement. Supports vascular, cardiac, and orthopedic procedures. Benefits: precise anatomical visualization, reduced radiation dose options, and improved workflow via ergonomic design and wireless footswitch. Integrates with DICOM networks for image storage/transfer.

Clinical Evidence

Bench testing only. No human clinical studies. Performance validated using anthropomorphic and anatomical phantoms representing adult and pediatric populations. Board-certified radiologist performed image quality assessment, concluding image quality and dose performance are comparable to the predicate device.

Technological Characteristics

Mobile C-arm with mono-block high-voltage generator and flat panel detector (aSi or CMOS). Active cooling. Connectivity: DICOM 3.0 (RJ45/WLAN). Software: ZAIP image processing. Electrical: 100-240 VAC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-43, IEC 60601-2-54, IEC 60825-1 (laser).

Indications for Use

Indicated for general populations, including infants, children, and adults, for pulsed and continuous fluoroscopic imaging during diagnostic, interventional, and surgical procedures (vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room). Contraindicated for mammography.

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 FD (K061534)

Related Devices

K161976 — Ziehm Solo FD · Ziehm Imaging GmbH · Oct 6, 2016
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K203504 — Cios Flow · Siemens Medical Solutions USA, Inc. · Dec 22, 2020
K210055 — Cios Alpha · Siemens Medical Solutions USA, Inc. · Feb 5, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 20, 2019 Ziehm Imaging GmbH % Steve Seeman Director of Regulatory Affairs and Ouality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO, FL 32822 Re: K193230 Trade/Device Name: Ziehm Vision FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: November 8, 2019 Received: November 25, 2019 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 {1}------------------------------------------------ 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 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 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 Mills, Ph.D. Division 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) K193230 Device Name Ziehm Vision FD ## Indications for Use (Describe) The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and as vascular, cardiac, angiographic, cholangiography, endoscopic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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/1 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 sans-serif font and is a gradient of teal, with the left side being a lighter shade and the right side being a darker shade. 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 ## Volume 005 510 (k) Summary November 08, 2019 In accordance with 21 CFR §807.92 the following 510(k) summary information is provided: | Submitter Address: | Ziehm Imaging GmbH | |------------------------------------|------------------------------------------------------| | | Donaustrasse 31 | | | 90451 Nuremberg | | | Germany | | | Phone: + 49.911.2172-0 | | | Fax: +49.911.2172-390 | | Primary Contact Person / Agent: | Steve Seeman | | | Director of Regulatory Affairs and Quality Assurance | | | Ziehm Imaging, Inc. | | | Phone: (480) 503 8010 ext 7011 | | | Fax: (480) 503-8011 | | | E-Mail: Steve.Seeman@Ziehm.com | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains a logo and the word "ziehmimaging". The logo is a circular design with a stylized figure inside, possibly representing a person with arms outstretched. The text "ziehmimaging" is written in a sans-serif font, with a gradient effect that transitions from a darker teal to a lighter teal color. | Device (Trade Name): | Ziehm Vision FD | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | unknown | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Regulation number: | 21CFR 892.1650 | | Regulation Description: | Image-intensified fluoroscopic x-ray system | | Device: | Interventional fluoroscopic x-ray system | | Product Code: | OWB, JAA | | Predicate Device: | Ziehm Vision FD (K061534) | | Regulation number: | 21CFR 892.1650 | | Regulation Description: | Image-intensified fluoroscopic x-ray system | | Device: | Interventional fluoroscopic x-ray system | | Product Code: | OWB, JAA | | General Description: | The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces. | | Intended Use | The Ziehm Vision FD is a mobile C-arm providing image data by means of a non-contact noninvasive x-ray technique during medical procedures and stores them temporarily. The system can be used for all medical indications where fluoroscopy is required. 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. | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic on the left and the word "ziehmimaging" on the right. The circular graphic contains a stylized image of a person inside of a circle. The text is in a teal color and appears to be a sans-serif font. The system is intended for use with human bodies covering structures such as but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication. Indications for Use: The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. Technology: The proposed modified device Ziehm Vision FD C-arm employs the same fundamental control, and scientific technology as that of our predicate device Ziehm Vision FD C-arm (K061534). > 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 FD C-arm (K061534). > Software architecture design is nearly identical to that of the predicate device Ziehm Vision FD C-arm (K061534). > modification of the software to support, lower dose with functionality, processing applications related to the optional low dose range, image, Variable beam limiting device, and device specific features. > The primary modifications of the C-Arm include a larger but virtually the same medical grade Image receptor, and a new CMOS image receptor as that of the predicate device Ziehm Vision FD Carm (K061534). virtual beam limiting device for precise collimating to anatomical structures, new pre-filter for lower skin entrance dose imaging, incorporation of mechanical design improvements in the C-Arm and mobile workstation balancinq, locks, and maneuverability improving operator workflow during extended procedures while keeping the essential profile of our predicate device Ziehm Vision FD C-arm (K061534). Summary of Technological The comparisons of the predicate device and the modified Ziehm Vision Characteristics: FD show, the scientific and technology characteristics of the Ziehm Vision FD are substantial equivalence to the predicate device Ziehm Vision FD (K061534) ### Substantial Equivalence Table {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for ziehmimaging. The logo consists of a circular emblem on the left and the word "ziehmimaging" on the right. The emblem 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. | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K061534) | Comparable Properties Substantial Equivalence Discussion | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Unknown at this time | K061534 | TBD | | Product Codes | OWB (interventional fluoroscopic x-ray system) Subsequent: JAA (system, x-ray, fluoroscopic, image- intensified) | OWB (interventional fluoroscopic x-ray system) Subsequent: JAA (system, x-ray, fluoroscopic, image- intensified) | Identical | | Device Image/ General Overview | Image: Ziehm Vision FD 8"x 8" Image: Ziehm Vision FD 12"x 12" | Image: Ziehm Vision FD | The modified Ziehm Vision FD and the predicate Ziehm Vision FD (K061534) share the same general design. The predicate and new device variant share a substantial equivalence with regard to but not limited to the intended use, indications for use, operational functionality of imaging, use of the same mono block generator designs, X-ray tube types, thermal management control and radiation control, general system software, user interface controls, imaging acquisition, dimensional features, scientific technologies, risk assessment, risk analysis, safety and effectiveness. The variants between the predicate and the new device do not raise new safety or effectiveness concerns. | | X-ray Generator Maximum Parameter | • Variant A0: max. 2.0 kW, max. 110 kV, max. 20 mA • Variant A1: max. 2.4 kW, | Variant A0: max. 2.0 kW, max. 110 kV, max. 20 mA | Predicate Ziehm Vision FD (K061534) and modified Ziehm Vision FD share the same generator variant A0. | | | | | | | Pulsed Fluoroscopy: Operating values | max. 120 kV, max. 24 mA • Variant A0: kV range: 40 - 110 kV mA range: 0.2 - 16 mA • Variant A1: kV range: 40 - 120 kV mA range: 0.2 - 20 mA (8" FPD) mA range: 0.2 - 24 mA (12" FPD) | Variant A0: kV range: 40 - 110 kV mA range: 0.2 - 20 mA | The new generator (variant A1) has a higher maximum power output, functions of 120 kV @ 24mA. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. Predicate Ziehm Vision FD (K061534) and modified Ziehm Vision FD share the same generator variant AO. The new generator (variant A1) has a higher maximum power output. | | Pulsed Fluoroscopy: Pulse and Duration | • pulse width: 7 - 23 ms (12" FPD Fujifilm aSi) 10 - 40 ms (12" FPD Varex, 8" FPD Varex aSi/CMOS) • pulse rate: 1, 2, 4, 8, 12.5, 25 pulse/s 1, 2, 5, 10, 15, 30 pulse/s | • pulse width: 10 - 30 ms • pulse rate: 50 Hz: 1, 2, 4, 8, 12.5, 25 pulse/s 60 Hz: 1, 2, 5, 10, 15, 30 pulse/s | Although not identical the predicate Ziehm Vision FD (K061534) and modified Ziehm Vision FD both use the identical basic generator with Pulsed Fluoroscopy. They both incorporate features and operational parameters, such as but not limited to pulse fluoroscopy technology, pulse duration and pulse width control delivered power, X-ray tube anode loading, and heat dissipation. Pulse width is up to 40 ms as maximum and pulse rate of 25 p/s or 30 p/s are possible for modified Ziehm Vision FD, depending on the device configuration. These changes do not | | Digital Radiography (Snapshot) / Operating Values | • Variant A0: kV range: 40 - 110 kV mA range: up to 20 mA • Variant A1: kV range: 40 - 120 kV | • kV range: 40-110 kV • mA range: up to 20 mA | raise new safety or effectiveness concerns with regard to the predicate device. Although the modified device is not identical to the predicate K061534. The general system exposure control | | | mA range: up to 20 mA (8" FPD Varex aSi) mA range: up to 24 mA (8" FPD Varex CMOS, 12" FPD Varex aSi, 12" FPD Fujifilm aSi) | | technology and operational functionality are identical in these regards for all available variants. Only the system programmable settings which define the limits of usable mA and kV are different. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | Thermal Management | Active cooling | Active cooling | Identical | | X-ray Tube | | | | | Tube Type | stationary anode | stationary anode | Identical | | Beam Limiter/ Collimator | | | | | Collimator System | Devices with 8" x 8" Flat Panel Detector: • Dedicated pre- collimator for FPD • Collimator Rotation: +/- 90° • Iris Collimator: 50 – 198 mm diameter • Asymmetric Slot Collimator: 50 – 198 mm diameter • Virtual Collimation without radiation Devices with 12" x 12" Flat Panel Detector: • Dedicated pre- collimator for FPD • Collimator Rotation: +/- 90° • Iris Collimator: 50 – 307 mm diameter • Asymmetric Slot Collimator: 50 – 307 mm diameter • Virtual Collimation without radiation | Devices with 8" x 8" Flat Panel Detector: • Dedicated pre- collimator • Collimator Rotation: +/- 90° • Iris Collimator: 50 – 198 mm diameter • Asymmetric Slot Collimator: 50 – 198 mm diameter • Virtual Collimation without radiation Devices with 12" x 12" Flat Panel Detector: • N/A | The collimator system for the predicate and the modified Ziehm Vision FD with 8" x 8" Flat Panel Detector is identical. Since there is also a 12" x 12" Flat Panel Detector for the modified Ziehm Vision FD, a larger collimator is used. Even though the size is different the general design of both collimator systems is the same. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features the logo of Ziehm Imaging, a company specializing in medical imaging solutions. The logo consists of two distinct elements: a stylized globe-like icon on the left and the company name "ziehmimaging" on the right. The globe icon is rendered in a light teal color, while the company name is presented in a gradient of teal shades, transitioning from lighter to darker hues from left to right. Ziehm Vision FD - Special 510(k) Submission {8}------------------------------------------------ Image /page/8/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 graphic features a stylized human figure inside a globe-like structure. The text is in a teal color, with the color gradient changing from light to dark from left to right. {9}------------------------------------------------ Image /page/9/Picture/1 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 graphic features a stylized human figure inside a circle with orbital lines, suggesting a focus on medical imaging and technology. ### I mage Detector Image /page/9/Figure/3 description: This image shows two flat panel detectors, both labeled as image detectors. The detector on the left has two variants: aSi FPD and CMOS FPD, with details on their type and scintillator. The detector on the right lists its type as Amorphous Silicon Flat Panel Detector (aSi) and its scintillator as Cesium-Iodide (CsI). The detector sizes are also listed, with the left detector having a variant of 20cm x 20cm (8"x 8") aSi and the right detector having a size of 19.9 cm x 19.9 cm. Although not identical in the cosmetic design of the housing, both devices use similar safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD). These changes do not raise safety new or effectiveness concerns with regard the to predicate device. Even though the detector materials of the Flat Panel Detector (FPD)/(SSXI) are not identical, both devices use solid state X-rav imagers (FPDs) having similar advantageous of higher image stability, higher DQE, image contrast range and higher qeometric sharpness with regard to magnetic earth field effects which can distort image an as compared to an image intensifiers (II). changes These do not raise new safety or effectiveness concerns with regard to the predicate device. The modified device and the predicate both use Solid State X-ray Imagers (FPD). The dimensions of the detectors are not identical but are very similar in image area for 8″ x 8″. The modified Ziehm Vision FD introduces Flat Panel Detectors with 12" x 12" , which did not exist in the predicate. The detector matrices differ due to different pixel pitches. For the resulting {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon 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. #### Variant 20.5cm x 20.5cm (8″x 8″) CMOS: - Size: 20.5 cm x 20.5 cm - Detector matrix: 2,048 x 2,048 pixels - Magnifier 1: 1,536 x 1,536 pixels - Magnifier 2: - 1,024 x 1,024 pixels • Dynamic Range: - 1 x 1 binning: 84 dB - 1 x 2 binning: 95 dB - System resolution (Nyquist): 5 lp/mm #### Variant 30cm x 30cm (12″x 12″) aSi: - 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 - Dynamic Range: 94 dB - · System resolution (Nyquist): 2.6 lp/mm # Variant 30.7cm x - 30.7cm (12″x 12″) aSi: - Size: 31 cm x 31 cm - Detector matrix: 2,048 x 2,048 pixels - Magnifier 1: - 1,536 x 1,536 pixels • Magnifier 2: - 1,024 x 1,024 pixels • Dynamic Range: ≥86 dB - · System resolution (Nyquist): 3.3 lp/mm ### Anti-Scatter Grids image on the monitor there is no significant difference because the image processing steps are equivalent. These changes do not new safety raise or effectiveness concerns reqard the with to predicate device. {11}------------------------------------------------ Image /page/11/Picture/1 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 graphic features a stylized human figure inside a globe-like structure. The text is in a teal color, with a gradient effect that transitions from lighter to darker shades. Fixed antiscatter grid optional removable anti- scatter grid fixed anti-scatter grid: Pb 8/70 Removable Grid: Pb fixed anti-scatter grid: Pb 8/40 Removable Grid: N/A, fixed anti-scatter grid only The grids are equivalent for the predicate and modified Ziehm Vision FD. The predicate Ziehm Vision FD (K061534) is equipped with a fixed antiscatter grid only, not a anti-scatter removable grid. However, the grid material and type of antiscatter grid is comparable to the modified Ziehm Vision FD. These changes do not new safety raise or effectiveness concerns with regard to the predicate device. ### Laser Positioning Device 8/70 Laser Positioning Device on Generator (optional) Image /page/11/Picture/11 description: This image shows a close-up of a white device with warning labels on top. The text "Class 2M (IEC 60825-1), 635 nm" indicates that the device is a Class 2M laser product with a wavelength of 635 nanometers. The warning labels on the device include a laser hazard symbol and other safety information. Class 2M (IEC 60825-1), 635 nm Laser Positioning Device on Image Detector (optional) Image /page/11/Picture/14 description: The image shows a close-up of a black and white electronic device. The device has a square screen in the center, surrounded by a black frame. There are two small buttons on the top corners of the device. The device appears to be a type of medical or scientific instrument. Class 2M (IEC 60825-1), 635 nm Image /page/11/Picture/16 description: The image shows a close-up of a white, rectangular device with a cylindrical component on top. The device has warning symbols, including a radiation symbol and a laser warning symbol. Two arrows point to small, circular indentations on the cylindrical component. The device appears to be a piece of medical or industrial equipment. Class 2M (IEC 60825-1), 635 nm Image /page/11/Picture/18 description: The image shows a close-up of a piece of equipment with a black, textured surface. A white square and circle are drawn on the surface. Two arrows point to screws on the top corners of the equipment. The equipment appears to be part of a larger structure, possibly a machine or a device. Nearly Identical and equivalent laser positioning device Although not identical in location they are nearly identical laser positioning and functionality for both predicate and modified device. These changes do not safety raise new or effectiveness concerns with regard to the predicate device. #### Electrical Requirements Electrical Requirements - · Power supply: 100-240 VAC (± 10%), 50/60 Hz - Current consumption: 100-120 V: 10 A continuous, 22 A shorttime 200-240 V: 8 A - · Power supply: 100-240 VAC (± 10%), 50/60 Hz - Current consumption: 100-120 V: 10 A continuous, 22 A short time 200-240 V: 8 A Equivalent electrical specifications for predicate and modified Ziehm Vision FD. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, surrounded by orbital lines. To the right of the graphic is the company name, "ziehmimaging", written in a gradient teal color. continuous, 16 A shorttime - Max. impedance: 100-200 V: ≤ 0.3 Ω 220-240 V: ≤ 0.6 Ω • Class I equipment, Type B continuous, 16 A shorttime - Max. impedance: - < 0.6 Ω - Class I equipment, Type B | Mechanics | | | | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Source-Image Receptor Distance (SID) | 109 cm | 111 cm | Source to Image Receptor Distance for the predicate and the modified device Ziehm Vision FD are not identical, but very similar. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | Vertical Free Space | 87 cm | 89.5 cm | Vertical free space for the predicate and the modified device Ziehm Vision FD are not identical, but very similar. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | C-arm Depth | 68 cm | 68 cm | Identical | | Width | 80 cm | 80 cm | Identical | | Length of Mobile Stand | • 160 / 182 cm* (20/20 135° orbital) • optional: 180 / 202 cm* (20/20 165° orbital lowered C, 20/20 165° orbital with lifting column expansion) • optional: 176 / 198 cm* (31/31 165° orbital) * depending on configuration | 160 / 182 cm | The length of the predicate and the modified device is similar but not identical. The dimensions vary for the modified Ziehm Vision FD depending on the configuration of image receptor size. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | Height of Mobile Stand | • 155 / 200 cm* (20/20 135° orbital) • optional: 155 / 197 cm* (20/20 165° orbital lowered C, 31/31 165° orbital) • optional: 158 / 220 cm* (20/20 165° | 158 / 201 cm | Although not identical the difference between the predicate and modified device is a result of different configurations of the device. The dimensions vary for the modified Ziehm Vision FD | | | orbital with lifting column expansion) * depending on configuration | | depending on the configuration of image receptor size. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | Manually Operated A-Axis (angulation) | +/- 225° (450°) | +/- 225° (450°) | Identical | | Manually Operated B-Axis (swiveling) | +/- 10° (20°) | +/- 10° (20°) | Identical | | Manually Operated C-Axis (orbital) | -120° / +45° (165°) | -90° / +45° (135°) | Although the modified Ziehm Vision FD is not identical the additional 30° of rotational movement in the C-Axis as compared to the predicate provides an improved user range of motion when performing oblique imaging and in no way diminishes or changes the devices effectiveness, therefore, the operation of the C-Axis is substantially equivalent to the predicates. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | | Manually Operated Y-Axis (horizontal) | 22 cm | 22 cm | Identical | | Motor Driven Z-Axis (vertical) | 42 cm optional: 63 cm | 43 cm | Although not identical, the basic configuration of predicate and modified device is equivalent. The modified device also provides an optional extended lift column which results in different dimensions. The…