Who is the manufacturer of Ziehm Vision FD?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Vision FD (K231700).

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

K231700 · Ziehm Imaging GmbH · OWB · Dec 15, 2023 · Radiology

Device Facts

Record ID	K231700
Device Name	Ziehm Vision FD
Applicant	Ziehm Imaging GmbH
Product Code	OWB · Radiology
Decision Date	Dec 15, 2023
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 adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists 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; provides real-time medical imaging for surgical/interventional procedures. Inputs: X-ray radiation passing through patient anatomy; captured by flat panel detector (FPD). Transformation: High-voltage generator produces X-rays; FPD converts X-rays to digital signals; system processes signals via Ziehm Adaptive Image Processing (ZAIP) and recursive/edge enhancement filters. Outputs: Live fluoroscopic images, cine loops, and digital subtraction images displayed on high-resolution monitors. Used in OR, clinic, or emergency settings by physicians/technicians. Healthcare providers use visual output to localize pathology and guide interventions. Benefits: Real-time visualization assists clinical outcomes; IGZO detector technology provides high-resolution imaging; wireless footswitch allows optimal surgeon positioning.

Clinical Evidence

Bench testing only. No clinical data. Performance validated using anatomical phantoms representing adult and pediatric populations. Radiologist assessment of image sets confirmed image quality is comparable to the predicate device. Compliance with 21 CFR 1020.30-32, electrical safety (ANSI/AAMI ES60601-1), and electromagnetic compatibility (IEC 60601-1-2) demonstrated.

Technological Characteristics

Mobile C-arm with mono-block high-voltage generator and flat panel detector (FPD). FPD types: a-Si, CMOS, and IGZO (Indium gallium zinc oxide) with Cesium-Iodide scintillator. 4-axis manual/1-axis motorized movement. Connectivity: DICOM 3.0, USB, DVD, wireless/wired network. Software: Linux-based (Ubuntu). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, ISO 14971.

Indications for Use

Indicated for medical imaging in adults and pediatric populations during diagnostic, interventional, and surgical procedures, including pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy. Not for direct radiographic film exposure, 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 FD (K193230)

Related Devices

K161976 — Ziehm Solo FD · Ziehm Imaging GmbH · Oct 6, 2016
K233380 — TRIDENT Mobile Fluoroscopy System · Dornier Medtech America · Jun 26, 2024
K090590 — VERADIUS, MODEL 718-130 · Philips Medical Systems North America Co. · Mar 16, 2009
K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD) · GEMSS HEALTHCARE CO., LTD. · Nov 16, 2023
K170946 — Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant · Skanray Technologies Private Limited · Nov 24, 2017

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 15, 2023 Ziehm Imaging GmbH c/o Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY Re: K231700 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 23, 2023 Received: November 24, 2023 Dear Ms. Milanova: 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. 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 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231700 Device Name Ziehm Vision FD ## Indications for Use (Describe) The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists 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) | |-------------------------------------------------| |-------------------------------------------------| X 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 on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a person inside a globe. The text is in a teal color and is written in a sans-serif font. #### 510k Summary K231700 - November, 23 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 | Tsvetelina Milanova Specialist Regulatory Affairs Ziehm Imaging GmbH Phone: +49 911 66067 219 Fax: +49 172 8651712 | | Secondary Contact Person: | Stefan Fiedler Director QM/RA Ziehm Imaging GmbH Phone: +49 911 66067 219 Fax: +49 172 8651712 | | US Agent | Kevin Bridgman VP Quality Assurance & Regulatory Affairs Ziehm-Orthoscan, Inc. 14555 N 82nd St Scottsdale AZ, 85260 | | Device (Trade Name): | Ziehm Vision FD | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Regulation: | 21CFR 892.1650 | | Regulation Description: | Image-intensified fluoroscopic x-ray system | 510(k) Summary {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 company name "ziehmimaging" on the right. The graphic features a stylized human figure within a globe-like structure. The text is in a teal color and appears to be a sans-serif font. | Product Code: | OWB , JAA | |---------------------------------|---------------------------------------------| | Product Class: | II | | Predicate Device: | K193230 Ziehm Vision FD | | Decision Date: | 20/12/2019 | | Regulation: | 21CFR 892.1650 | | Regulation Description Name: | Image-intensified fluoroscopic x-ray system | | Product Code: | JAA; OWB | | Device Class: | II | Device Class Summary of Technological Characteristics 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 Xray 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. modified device Ziehm Vision FD employs The proposed the same fundamental control, and substantially equivalent scientific technology as that of predicate device Ziehm Vision FD (K193230). Software architecture our design is substantially equivalent to that of the predicate Ziehm Vision FD. The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD). The new 8 inch IGZO FPD is an addition to already introduced CMOS and a-Si FPD. 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) 8 inch CMOS, 12 inch a-Si and the only difference to the predicate Ziehm Vision FD is the additional 8 inch IGZO panel. The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision FD are {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, surrounded by orbital lines. To the right of the graphic is the company name, "ziehmimaging," written in a teal-colored, sans-serif font. substantially equivalent as those of the Ziehm Vision FD predicate device (K193230). The Ziehm Vision FD is a mobile C-arm providing image data by means of a Intended Use non-contact noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision FD is intended for use in all medical indications requiring fluoroscopy. > The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system is intended for use with human bodies covering such structures but not limited to the following, e.g. 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 adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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. # Device Comparison Table The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device: | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230) | Comparable Properties Substantial Equivalence Discussion | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K231700 | K193230 | - | | 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 | | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230) | Comparable Properties Substantial Equivalence Discussion | | Device Image/ General Overview | Image: Ziehm Vision FD 8"x 8" Image: Ziehm Vision FD 12"x 12" | Image: Ziehm Vision FD 8"x 8" Image: Ziehm Vision FD 12"x 12" | The modified Ziehm Vision FD and the predicate Ziehm Vision FD (K193230) share the same outer design. The flat panel detectors are identical in the design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 12 inch aSi, 8 inch CMOS and the difference to the predicate Ziehm Vision FD is the new 8 inch IGZO FPD. The 8 inch and 12 inch a-Si Varex FPD's have been discontinued. | | X-ray Generator | | | | | Maximum Output | Variant A0: 2.0 kW Variant A1: 2.4 kW | Variant A0: 2.0 kW Variant A1: 2.4 kW | Identical. | | Pulsed Fluoroscopy: Pulse and Duration | • pulse width: 7 - 23 ms (12" FPD) 10 - 40 ms (8" FPD) • pulse rate: 1, 2, 4, 8, 12.5, 25 pulse/s (8" and 12" FPD) 1, 2, 5, 10, 15, 30 pulse/s (8" FPD) | • 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 | Substantial equivalence. The 8 inch and 12 inch a-Si Varex FPD's have been discontinued.. | | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230) | Comparable Properties Substantial Equivalence Discussion | | 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 mA range: up to 24 mA (8" and 12" FPD) | • Variant A0: kV range: 40 -110 kV mA range: up to 20 mA • Variant A1: kV range: 40 - 120 kV 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) | Substantial equivalence. The 8 inch and 12 inch a-Si Varex FPD's have been discontinued. | | Image Detector | | | | | Image Detector | Flat Panel Detector Image: Flat panel detector | Flat Panel Detector Image: Flat panel detector | Substantial equivalence. They are identical in the outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptor (SSXI / FPD) The modified Ziehm Vision FD has additionally new 8 inch IGZO (Indium gallium zinc oxide) flat panel detector. The 8 inch and 12 inch a-Si Varex FPD's have been discontinued. | | Detector Technology | Variant aSi FPD: • Type: Amorphous Silicon Flat Panel Detector (aSi) • Scintillator: Cesium- Iodide (CsI) Variant CMOS FPD: • Type: Complementary Metal Semi-conductor) • Scintillator: Cesium- Iodide (CsI) Variant IGZO FDP: • Type: Indium gallium zinc oxide • Scintillator: Cesium- Iodide (CsI) | Variant aSi FPD: • Type: Amorphous Silicon Flat Panel Detector (aSi) • Scintillator: Cesium-Iodide (CsI) Variant CMOS FPD: • Type: Complementary Metal Semi-conductor) • Scintillator: Cesium-Iodide (CsI) | Substantial equivalence. IGZO based detectors are manufactured using processes that are similar to aSi detectors. The slight differences in used sensor glass technology does not have influence on safety and effectiveness of the C-arm product. | | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230) | Comparable Properties Substantial Equivalence Discussion | | Detector Sizes | Variant 21cm x 21cm (8"x8") CMOS: • Size: 21 cm x 21 cm • Detector matrix: 2,053 x 2,051 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 31cm x 31cm (12"x12") 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 Variant 21cm x 21cm (8"x8") IGZO: • Size: 21 cm x 21 cm • Detector matrix: 1,536 x 1,536 pixels • Magnifier 1: 1,024 x 1,024 pixels • Magnifier 2: 768 x 768 pixels • System resolution (Nyquist): 3.7 lp/mm | Variant 20.5cm x 20.5cm (8"x8") 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 20cm x 20cm (8"x8") aSi: • 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 • Dynamic Range: 94 dB • System resolution: 2.6 lp/mm Variant 30cm x 30cm (12"x12") 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 30,7 cm x 30.7 cm (12"x12") aSi: • Size: 31 cm x 31 cm • Detector matrix: 2,048 x 2,048 pixels • Magnifier 1: 1,536 x 1,536 pixels | Substantial equivalence. The active pixel area of the detector types are not identical but are very similar in image area of approx. 8 inch x 8 inch. The modified device Ziehm Vision FD with IGZO has a higher resolution size in comparison to predicate device with 8 inch a-Si FPD, which leads to better image quality. All other differences with regard to the used technology have no influence on safety and effectiveness of the C arm. Variant 20cm x 20cm (8"x8") aSi and Variant 30cm x 30cm (12"x12") aSi were discontinued. | | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230) | Comparable Properties Substantial Equivalence Discussion | | Anti-Scatter Grids | | Magnifier 2: 1,024 x 1,024 pixels System resolution (Nyquist): 3.3 lp/mm | | | Fixed anti- scatter grid | fixed anti-scatter grid: CMOS (8inch) Pb 8:1/70 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm | fixed anti-scatter grid: CMOS (8inch) Pb 8/70 | Substantial equivalence. The grids for the CMOS and the IGZO FPD are identical for the predicate and the modified Ziehm Vision FD. | | optional removable anti-scatter grid | Removable Grid: CMOS (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm Image: [removable anti-scatter grid] | Removable Grid: CMOS (8inch) Pb 8:1/70 lines/cm a-Si (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm | Substantial equivalence. The grids for the CMOS and the IGZO FPD are identical for the predicate and the modified Ziehm Vision FD. The grid of the a-Si (12 inch) FPD has a slightly different value compared to the anti-scatter grids for the other two FPD's. The 8 inch and 12 inch a-Si Varex FPD's have been discontinued. | | Mechanics | | | | | Model | Modified Ziehm Vision FD | Predicate Ziehm Vision FD (K193230)…