Who is the manufacturer of Ziehm Solo FD?

Ziehm Imaging GmbH filed the 510(k) submission for Ziehm Solo FD (K231669).

What is the FDA product code for Ziehm Solo 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 Solo FD?

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

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

K231669 · Ziehm Imaging GmbH · OWB · Dec 12, 2023 · Radiology

Device Facts

Record ID	K231669
Device Name	Ziehm Solo FD
Applicant	Ziehm Imaging GmbH
Product Code	OWB · Radiology
Decision Date	Dec 12, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Ziehm Solo 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 Story

Mobile fluoroscopic C-arm system; captures, stores, and displays X-ray images for surgical/interventional guidance. Input: X-rays generated by mono-block generator; detected by 8-inch CMOS or IGZO flat panel detector. Operation: Physician-directed; mobile stand with C-arm; CAN BUS control system; optional viewing station. Output: Real-time fluoroscopic images, cine loops, digital subtraction. Clinical utility: Assists in localizing pathological areas, visualizing anatomy/implants during procedures. Benefits: Real-time visualization, low-dose functionality, improved image quality via IGZO detector. Used in OR, clinic, emergency settings.

Clinical Evidence

Bench testing only. Non-clinical imaging and dose testing performed using anatomical phantoms representing adult and pediatric populations. Radiologist assessment of image sets confirmed image quality is comparable to reference device (K193230). Compliance with 21 CFR 1020.30-32 and IEC 60601 series standards verified.

Technological Characteristics

Mobile C-arm; mono-block X-ray generator; 8-inch CMOS or IGZO flat panel detectors (CsI scintillator); CAN BUS control; laser positioning; wireless/wired footswitch; DICOM 3.0 connectivity; Linux-based OS. Standards: ANSI/AAMI ES60601-1, 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 using pulsed and continuous fluoroscopic imaging for diagnostic, interventional, and surgical procedures, including pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room applications. Not for mammography or use near MRI systems.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Ziehm Solo FD (K161976)

Reference Devices

Ziehm Vision FD (K193230)

Related Devices

K234109 — Ziehm Solo FD · Ziehm Imaging GmbH · Jan 26, 2024
K231692 — Ziehm Vision RFD · Ziehm Imaging GmbH · Nov 20, 2023
K223410 — Cios Select (VA21) Flat Panel · Siemens Medical Solutions USA, Inc. · Dec 7, 2022
K243646 — Ziehm Solo FD · Ziehm Imaging GmbH · Mar 17, 2025
K203504 — Cios Flow · Siemens Medical Solutions USA, Inc. · Dec 22, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ December 12, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal 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 the word "ADMINISTRATION" in a smaller font size below. Ziehm Imaging GmbH % Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY Re: K231669 Trade/Device Name: Ziehm Solo FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: November 13, 2023 Received: November 14, 2023 Dear Tsvetelina 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 (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) K231669 Device Name Ziehm Solo FD ## Indications for Use (Describe) The Ziehm Solo 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a globe with a human figure inside. The text is in a teal color and a serif font. 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 December, 7 2023 In accordance with 21 CFR §807.92 the following 510(k) K231669 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 & Requlatory Affairs Ziehm-Orthoscan, Inc. 14555 N 82nd St Scottsdale AZ, 85260 | | Device (Trade Name): | Ziehm Solo FD | | Common /Usual Names: | Mobile Fluoroscopic C-Arm | | Requlation: | 21CFR 892.1650 | | Regulation Description: | Image-intensified fluoroscopic x-ray system | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe-like icon on the left, followed by the company name "ziehmimaging" in a teal-colored sans-serif font. The globe icon features a human figure within intersecting circles, giving it a modern and technological appearance. | Product Code: | OWB; JAA, OXO | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification: | II | | Predicate Device: | K161976 Ziehm Solo FD | | Reference Device | K193230 Ziehm Vision FD | | Decision Date: | 10/06/2016 | | Regulation: | 21CFR 892.1650 | | Regulation Description Name: | Image-intensified fluoroscopic x-ray system | | Product Code: | OWB; JAA, OXO | | Summary of Technological Characteristics | The Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the control of the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results. The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system. The mechanical C-Profile supports the generator, the flat panel detector and an integrated laser positioning device. The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand. The proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo 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 FPD. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding | 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized human figure inside a circle with orbital lines around it. The text is in a teal color and appears to be a sans-serif font. for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo 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 Solo FD are substantially equivalent as those of the Ziehm Solo FD predicate device (K161976). - Intended Use The Ziehm Solo FD is a mobile C-arm providing image data by means of a noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Solo 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 svstem 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. Indications for Use: The Ziehm Solo 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, cholanqiography, 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 Solo FD | Predicate Ziehm Solo FD (K161976) | Comparable Properties Substantial Equivalence Discussion | |------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | 510(k) Number | K231669 | K161976 | --- | | Product Codes | OWB (interventional fluoroscopic x-ray system) Subsequent: JAA (system, x-ray, fluoroscopic) | OWB (interventional fluoroscopic x-ray system) Subsequent: JAA (system, x-ray, fluoroscopic) | Identical | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a circle with curved lines. The company name is written in a teal sans-serif font. | Model | Modified Ziehm Solo FD | Predicate Ziehm Solo FD (K161976) | Comparable Properties Substantial Equivalence Discussion | |------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Image/ General Overview | image-intensified), OXO (image-intensified fluoroscopic x- ray system, mobile) Image: Modified Ziehm Solo FD | image-intensified), OXO (image-intensified fluoroscopic x-ray system, mobile) Image: Predicate Ziehm Solo FD (K161976) | 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 receptor (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo FD is the new 8 inch IGZO FPD. | | Model | Modified Ziehm Solo FD | Predicate Ziehm Solo FD (K161976) | Comparable Properties Substantial Equivalence Discussion | | X-ray Generator | | | | | Pulsed Fluoroscopy: Operating values | kV range: variant B0: 40 - 110 kV variant B1+B2: 40 - 120 kV mA range: variant B0: 0.2 - 16 mA variant B1: 0.2 - 16 mA variant B2: 0.2 - 20 mA | kV range: variant B0: 40 - 110 kV variant B1+B2: 40 - 120 kV mA range: variant B0: 0.2 - 16 mA variant B1: 0.2 - 16 mA variant B2: 0.2 - 16 mA | Substantial equivalent. The characteristic line was changed to 20mA, which has no effect on the safety as it is below the maximum dose. | | X-ray Tube | | | | | Tube Type | stationary anode | stationary anode | Identical. | | X-Ray Tubes | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 125kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 120kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | Substantial equivalent The maximal voltage of the X- Ray tube for variants B0, B1, and B2 have the max. Voltage up to 125kV, but as the generator is up to 120kV the value was given as 120kV. | | Monitors | | | | | Display Monitor | The device can be equipped with monitors of different sizes 19" Duo flat-screen monitor (optionally with Quick Release) 27" flat screen monitor | The device can be equipped with monitors of different sizes 19" DUO flat-screen monitor 24" flat screen monitor | Substantial equivalent. The 24" flat screen monitor has been discontinued by the manufacturer and have been replaced by 27" monitor. | | | Radiation Switches | | | | X-Ray foot switch | Cable bound footswitch (with or without protective bracket) optional: Wireless footswitch with an emergency cord the if battery is | Cable bound footswitch optional: Wireless footswitch with an emergency cord the if battery is low | Substantial equivalent All footswitches are available with | | Model | Modified Ziehm Solo FD | Predicate Ziehm Solo FD (K161976) | Comparable Properties Substantial Equivalence Discussion | | | low (with or without protective bracket) | | protective bracket. | | | Digital Imaging Processing | | | | Real-Time processing functions | • Recursive filter: 4 levels • Last Image Hold • Edge enhancement filter: 5 levels • Windowing and step windowing • Digital image rotation and reversal without radiation • Grayscale inversion • Digital collimators • Ziehm Adaptive Image Processing (ZAIP) | • Recursive filter: 4 levels • Stack filter 'Last Image Hold': 5 levels • Last Image Hold • Edge enhancement filter: 5 levels • Windowing and step windowing • Digital image rotation and reversal without radiation • Grayscale inversion • Digital collimators • Ziehm Adaptive Image Processing (ZAIP) | Substantial equivalent. Stack filter 'Last Image Hold' was discontinued. | | Appli- cation- Oriented Anato- mical Programs (AOAP) | • Bone: Extremities, Trunk • Heart, Abdomen, Soft, Uro (option) • Vascular: Extremities, Trunk, Bolus | • Bone: Extremities, Trunk • Abdomen, Soft, Uro (option), Long Procedure Spine • Vascular: Extremities, Trunk, Bolus | Substantial equivalent. Long procedure spine was discontinued. | | Model | Modified Ziehm Solo FD | Predicate Ziehm Solo FD (K161976) | Comparable Properties Substantial Equivalence Discussion | | Data Organizati on | • Patient-based data management with 16-image mosaic display • Pre-registration via DICOM Worklist (option) • Manual input or emergency registration • Calculated Dose Area Product (DAP) • DAP value tagged to stored image • Air Kerma dose display • Air kerma value tagged to the stored image • HIPAA security package (option) • Radiation Dose Structured Report (RDSR) • Video Output - Full HD SDI (split display) - 1920 x 1080p - 60Hz • Measured dose area product (DAP) with digital display (option)…