(25 days)
Ziehm Vision FD (K061534)
Not Found
No
The document describes a standard mobile fluoroscopy system with image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for medical imaging and diagnostic purposes, not for treating diseases or conditions.
Yes
The device is intended for use in providing medical imaging for general populations during diagnostic, interventional, and surgical procedures. It helps in visualizing complex anatomical structures and localizing regions of pathology, which are key aspects of diagnostic processes.
No
The device description clearly outlines hardware components such as a mobile stand, C-Profile support, mono-block high voltage generator assembly, Flat Panel image receptor, user touch screen, and display monitors. This indicates it is a hardware-based medical imaging system, not a software-only device.
Based on the provided information, the Ziehm Vision FD is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "providing medical imaging for general populations" and "visualizing complex anatomical structures and procedures" within the patient's body. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details a mobile fluoroscopy system with a C-arm, X-ray generator, and image receptor. This is a system designed for in vivo imaging (imaging within a living organism).
- Input Imaging Modality: The input modality is "Fluoroscopic x-ray," which is an in vivo imaging technique.
- Anatomical Site: The anatomical site is "human bodies covering structures such as but not limited to the following, e.g. organs, tissue, bones, implants." This refers to structures within the living patient.
IVD devices are designed to perform tests on samples taken from the human body, such as blood, urine, tissue, etc., to diagnose diseases or other conditions. The Ziehm Vision FD does not perform such tests. It is a medical imaging device used for visualizing internal structures during procedures.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed and continuous fluoroscopic imaging (X-ray)
Anatomical Site
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.
Indicated Patient Age Range
general populations. 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.
Intended User / Care Setting
Device labeling defines that only trained and instructed qualified personnel are allowed to operate the system.
The system may only be used in rooms used for medical purposes.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
The modified Ziehm Vision FD did not require live human clinical studies. Therefore, Ziehm Imaging GmbH conducted an image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken. Evaluation of the individual images arranged in image sets was conducted by a board-certified Radiologist.
Non-clinical image and dose Lab testing were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical image comparison study. Samples not specified beyond "sets of images" and "anthropomorphic phantoms". A board-certified Radiologist evaluated individual images. Radiologist conclusion, the image quality of the Ziehm Vision FD results in a comparable patient care to the Predicate device Ziehm Vision FD (K061534). and fulfils the requirements as stated by the intended use. The Radiologist's conclusion was that the image quality combined with a reduced patient dosage will result in a comparable patient care to the Predicate device Ziehm Vision FD (K061534). His comparison of the dose and images provided further evidence in addition to the laboratory performance data that the complete system works as intended and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ziehm Vision FD (K061534)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
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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. |
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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
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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. |
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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
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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.
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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
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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:
- Risk AnalysisRequired reviews |
-
Design reviews •
26
Image /page/26/Picture/1 description: The image features the logo of Ziehm Imaging. The logo consists of a circular emblem on the left and the company name "ziehmimaging" on the right. The emblem contains a stylized human figure inside a circular design, and the text is in a sans-serif font with a gradient color scheme.
- . Component testing
- Integration testing ●
- . Performance testing
- . Safety testing
- Product use testing ●
Performance bench testing included:
Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality. Further in line with UCM089742- Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Non-clinical image and dose Lab testing, were employed. Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision FD results in a comparable patient care to the Predicate device Ziehm Vision FD (K061534). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision FD Carm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision FD (K061534).
- Ziehm Imaging GmbH considers the modified Ziehm Vision FD to Conclusion: be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision FD (K061534) in accordance with its labeling.
End of 510(k) Summary