ARTIS genio floor; ARTIS icono.explore floor
Device Facts
| Record ID | K253752 |
|---|---|
| Device Name | ARTIS genio floor; ARTIS icono.explore floor |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | OWB · Radiology |
| Decision Date | Apr 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
ARTIS is a family of dedicated angiography systems developed for single plane and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS systems include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Device Story
Angiography system for diagnostic imaging and interventional procedures; utilizes multi-axis motorized C-arm, X-ray tube, flat panel detector, and high-voltage generator. Inputs: X-ray signals; outputs: 2D/3D images for visualization on ceiling-mounted displays. Operated by physicians in OR or interventional suites; table-side control modules and footswitches used for positioning and X-ray release. System supports advanced post-processing (I-Noise, Extended Overlay Reference) and DynaCT for 3D reconstruction. Enables catheter navigation, image-guided surgery, and spatial data synthesis. Benefits include improved visualization of vessels and internal structures, facilitating safe navigation of interventional devices and surgical planning.
Clinical Evidence
Bench testing only. Includes verification and validation of software, imaging performance (signal-to-noise, tube efficiency, homogeneity), mechanical testing (tilting/panning force, C-arm speed, repositioning accuracy), and clinical evaluation of images. No clinical trial data presented.
Technological Characteristics
Floor-mounted C-arm angiography system. Components: X-ray tube, Trixell 2121S flat panel detector, high-voltage generator, motorized patient table. Connectivity: DICOM, networked. Software: VE50B platform with advanced post-processing algorithms. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-43, ISO 10993-1, ISO 14971, IEC 62304.
Indications for Use
Indicated for single-plane and biplane diagnostic imaging and interventional procedures, including pediatric and obese patients. Procedures include cardiac, neuro, general, rotational, and multipurpose angiography, and whole-body radiographic/fluoroscopic procedures. Supports image-guided surgery, image fusion, navigation, and position-triggered spatial data synthesis. DynaCT option indicated for 2D-to-3D reconstruction of hard/soft tissues for diagnosis, planning, and follow-up.
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
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 23, 2026
Siemens Medical Solutions USA, Inc.
% Patricia Jones
Regulatory Affairs Professional
40 Libertry Blvd.
MALVERN, PA 19355
Re: K253752
Trade/Device Name: ARTIS genio floor; ARTIS icono.explore floor
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, IZI, JAA, JAK
Dated: November 25, 2025
Received: March 24, 2026
Dear Patricia Jones:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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, 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
Enclosure
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253752 | |
| Device Name ARTIS genio floor; ARTIS icono.explore floor | |
| Indications for Use (Describe) | |
| ARTIS is a family of dedicated angiography systems developed for single plane and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | |
| Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. | |
| Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. | |
| The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis. | |
| The ARTIS systems include also the software option DynaCT with following indications for use: | |
| DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. | |
| DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up. | |
| 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." | |
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510k Number: K253752
SIEMENS Healthineers
# 510(k) Summary: ARTIS genio floor (VE50B)
ARTIS icono.explore floor (VE50B)
Company: Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65
Malvern, PA 19355
Date Prepared: November 25, 2025
1. General Information:
Importer / Distributor:
Siemens Medical Systems USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site:
Siemens Healthcare GmbH
Siemensstr. 1
91301 Forchheim, Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D. Jones
Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Phone: (678) 575-8832
Email: patricia.jones@siemens-Healthineers.com
3. Device Name and Classification:
Trade Name: ARTIS genio floor;
ARTIS icono.explore floor
Classification Name: Image-intensified fluoroscopic X-ray System
Common Name: Interventional Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1650
Device Class: Class II
Primary Product Code: OWB,
Subsequent Product Codes: IZI, JAA, JAK
4. Legally Marketed Primary Predicate Device
Trade Name: ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
510(k) Clearance
K241572
Clearance Date: October 22, 2024
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Classification Name: Image-intensified fluoroscopic X-ray System
Common Name: Interventional Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1650
Device Class: Class II
Primary Product Code: OWB
Subsequent Product Codes: IZI, JAA, JAK
Total Product Life Cycle: All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.
Secondary Predicate
Trade Name: Artis one
510(k) Clearance: K133580
Clearance Date: April 28, 2014
Classification Name: Image-intensified fluoroscopic X-ray System
Common Name: Interventional Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1650
Device Class: Class II
Product Code: OWB
Subsequent Product Code: JAA
Total Product Life Cycle: All product Recall incidents are considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.
# 5. Device Description:
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems allow visualization of vessels within the human body. It is of the utmost importance to find the right projections so physicians can navigate catheters and other devices safely. The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems consist of a patient table and a multi-axis motorized c-arm that can be positioned around the patient and angulated in a double-oblique fashion iso-centering the region of interest between the X-ray tube and the flat panel detector. The X-ray generator is placed separately. The displays for visualizing the X-ray images are mounted at the ceiling with a movable display suspension system. System operation is executed via control modules table side so that the physician can move and position the table and c-arm adequately for best imaging while manipulating the catheters or other devices during the X-ray. X-ray release tableside via a footswitch.
Both systems are equipped with a C-arm, stand, flat panel detector, X-ray tube, collimator, high voltage generator, patient table, and image post-processing.
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems cover the complete range of angiographic applications, cardiac angiography, neuro-angiography, general
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angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, and radiographic/fluoroscopic procedures.
Images and operating elements are displayed on screens. Depending on the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems configuration, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information content in various layouts are used.
Post-processing can be conducted in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems are capable of 2D and 3D imaging. The c-arms can be mounted on the floor for the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems.
Other systems and software syngo Application Software, syngo X Workplace, Sensis Vibe, and or third-party systems may also be integrated into the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems screen configurations. Different screen configurations and layouts are possible in the examination and control rooms.
This 510(k) submission, Subject devices ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems will support the following modifications made to the Subject Devices in comparison to the Predicate Device.
The Subject devices ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems supports the following modifications.
| List of Modifications for ARTIS genio floor / ARTIS icono.explore floor (VE50B) Systems |
| --- |
| 1. Updated system software from VE40A to VE50B to support the following: |
| A. Updated Peristepping / Perivision |
| B. New Postprocessing Algorithms (Advanced I-Noise and Extended Overlay Reference) |
| C. Updated ARTIS Touch UI |
| D. Updated Collimators |
| E. Updated Common Application Hosting |
| F. Optional new Trixell 2121S Flat Detector |
| G. Updated User Interface |
| H. Updated ARTIS Profiles |
| 2. Updated Imaging System PC Hardware |
| 3. Updated Tilt & Basic Tables |
| 4. Update Floor Stand |
| 5. Updated 510(k) information for the Primary Predicate Device |
6. Indications for Use:
ARTIS is a family of dedicated angiography systems developed for single-plane and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
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Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography, and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.
The ARTIS systems can also support the acquisition of position-triggered imaging for spatial data synthesis.
The ARTIS systems also include the software option DynaCT with following indications for use:
DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
## 7. Substantial Equivalence:
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems is substantially equivalent to the legally marketed predicate listed in the table below:
Table 3: Predicate Device Comparable Properties for Subject Device Modifications:
| Predicate Device Name and Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
| --- | --- | --- | --- |
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (ceiling); Siemens | K241572 | 10/22/2024 | • Indications for Use Statement
• Updated system software from VE40A to VE50B
• Peristepping/Pervision
• I-Noise
• ARTIS Touch UI
• Collimator
• Common Application Hosting
• Flat Detector
• User Interface
• ARTIS Profiles
• Imaging System PC Hardware
• Table
• Floor Stand |
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SIEMENS Healthineers
| Artis one
Siemens | K133580 | 04/28/2014 | • Floor Stand
• Table |
| --- | --- | --- | --- |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems is designed as a set of components (C-arm, X-ray tube, and housing, flat panel detector, digital imaging system, collimator, generator etc.) that may be combined into a floor configuration to provide specialized angiography systems. Components used with ARTIS configurations are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Devices and the Predicate Devices are provided in Table 4 below for all modifications.
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Table 4: Summary of Comparison of Technological Characteristics
| Modifications | Subject Device
ARTIS genio floor /
ARTIS icono.explore floor (VE50B) systems | Predicate Device
ARTIS icono (VE40A)
K241572 | Comparison Results |
| --- | --- | --- | --- |
| New System Software/Hardware Changes | 1. Updated system software from VE40A to VE50B | System software version VE40A | Comparable:
System software VE40 was updated to support modifications 1A-2. All Software modifications conform to “Guidance for the Content of Premarket Submissions for Device Software Functions.”
Bench tests were conducted and found acceptable and did not raise any new safety or effectiveness issues.
All software validation data demonstrates that the Subject devices are as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use. All test results met all acceptance criteria. |
| | A. Updated Peristepping / Perivision
Visualization of the whole legs with a single contrast media injection • Flexible number of steps • Acquisition possible in portrait and landscape • DSA live display | Peristepping / Perivision available for ARTIS icono ceiling variant only | |
| | B. New Postprocessing Algorithms (Advanced I-Noise and Extended Overlay Reference) | iNoise | |
| | C. Updated ARTIS Touch UI | ARTIS Touch UI | |
| | D. Updated Collimators | Collimators | |
| | E. Updated Common Application Hosting | Third Party Interface (TPI) | |
| | F. Optional New Trixell 2121S Flat Detector | Trixell 2121CV | |
| | G. Updated User Interface | User Interface | |
| | H. Updated ARTIS Profiles | ARTIS Profiles | |
| | 2. Updated imaging system PC Hardware | Imaging system “ATIS” | |
| | 3. Updated Tilt & Basic Tables | Tilt and Basic Tables | |
| | 4. Updated Floor Stand | Floor Stand (Second Predicate Artis one K133580) | |
| | 5. Updated 510(k) information for the Primary Predicate Device. | | |
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# 9. Nonclinical Performance Testing:
During product development, non-clinical tests were conducted for the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems. The following non-clinical testing was conducted on the presented modifications: Updated Peristepping / Perivision testing includes peripheral imaging with and without subtraction. New Postprocessing Algorithms (Advanced I-Noise and Extended Overlay Reference) testing includes Real time image chain OGP parameters, Signal Noise, Strength Fluoro and Service parameter, and clinical evaluation of images. Updated ARTIS Touch UI testing includes touch user interface mounting and functionality and hardware security. Updated collimator testing includes collimation centrically and collimation rectangular. Common Application Hosting testing includes External application interface and common applicating hosting configuration and layout testing. New Flat Detector Trixell Pixium 2121S (also known as as21SDR) testing includes Tube efficiency, homogeneity, High Mid-Plane A, and testing to ensure correct modes are selected for detector operation on set parameters. Artis Profiles testing includes checks to verify available functionality to the clinical user. Table testing includes confirmation of range of tilting and panning force testing. Floor Stand testing includes C-arm speed, and reposition accuracy testing. Software functional, verification, and System validation testing were conducted with passing results.
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:
| Recog-nition # | Product Area | Title of Standard | Reference Number and Date | Standards Development Organization |
| --- | --- | --- | --- | --- |
| 19-46 | General II (ES/EMC) | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | ANSI AAMI |
| 19-36 | General II (ES/EMC) | Medical Electrical Equipment: Part 1: 1. Collateral Standard: Electromagnetic compatibility – Requirements and tests | 60601-1-2:2020 | IEC |
| 12-336 | Radiology | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | 60601-1-3:2021 | IEC |
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Healthineers
| Recognition # | Product Area | Title of Standard | Reference Number and Date | Standards Development Organization |
| --- | --- | --- | --- | --- |
| 12-273 | Radiology | Safety of laser products - Part 1: Equipment classification and Requirements | 60825-1:2014 (recognized 2007) | IEC |
| 5-137 | General I (QS/RM) | Graphical symbols for electrical equipment in medical practice | TR 60878:2022 | IEC |
| 13-79 | Software/ Informatics | Medical Device Software – Software Life Cycle Processes | 62304:2015 | IEC |
| 12-309 | Radiology | Medical electrical equipment - Part 2-28: Particular requirements for basic safety and essential performance of X-ray tube assemblies for medical diagnosis | 60601-2-28:2017 | IEC |
| 12-351 | Radiology | Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures | 60601-2-43:2022 | IEC |
| 12-348 | Radiology | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | 60601-2-54:2022 | IEC |
| 2-258 | Biocompatibility | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | 10993-1:2018 | ISO |
| 5-125 | General I (QS/RM) | Medical devices: Application of Risk management to medical devices | 14971:2019 | ISO |
| 5-134 | General I (QS/RM) | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | 15223-1:2021 | ISO |
| 14-579 | Sterility | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. | 17664-2:2021 | ISO |
| 6-483 | General Plastic Surgery/ General Hospital | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and | 60601-2-35:2020 | IEC |
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Healthineers
| Recog-nition # | Product Area | Title of Standard | Reference Number and Date | Standards Development Organization |
| --- | --- | --- | --- | --- |
| | | mattresses and intended for heating in medical use | | |
| 5-129 | General I (QS/RM) | Medical devices - Part 1: Application of usability engineering to medical devices | 62366-1:2020 | IEC |
| 12-341 | Radiology | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods | 62563-1:2021 | IEC |
| 12-344 | Radiology | Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays | 62563-2:2021 | IEC |
| 12-352 | Radiology | Digital Imaging and Communications in Medicine (DICOM) Set | PS 3.1:2023 | NEMA |
| 13-96 | Software/Informatics | Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements | 2900-1:2017 | ANSI UL |
| 13-104 | Software/Informatics | Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems | 2900-2-1:2017 | ANSI UL |
| 13-83 | Software/Informatics | Principles for medical device security - Risk management. | TIR57:2016 | AAMI |
| 5-132 | General I (QS/RM) | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | 60601-1-6:2020 | IEC |
| 19-22 | General II (ES/EMC) | Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. | TIR69:2017/(R2020) | AAMI |
| 19-48 | General II (ES/EMC) | American National Standard for Evaluation of Wireless Coexistence | USEMCSC C63.27-2021 | IEEE ANSI |
| 19-19 | General II (ES/EMC) | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of | TR 60601-4-2:2016 | IEC |
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| Recog-nition # | Product Area | Title of Standard | Reference Number and Date | Standards Development Organization |
| --- | --- | --- | --- | --- |
| | | medical electrical equipment and medical electrical systems | | |
| 5-135 | General I (QS/RM) | Medical devices - Information to be supplied by the manufacturer | 20417:2021 | ISO |
The modifications described in this Premarket Notification are supported with verification and validation testing.
## Verification and Validation:
Software Documentation for a Basic level of concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with medical devices containing software. Non-clinical tests were conducted on The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
The ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems were tested and found to be substantially equivalent for intended users, uses, and use environments through the design control verification and validation process. Customer employees are adequately trained in the use of this equipment.
Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse, or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. The responsibility for compliance with IEC 80001-1-2010 is the hospital.
## Summary:
Performance tests were conducted to evaluate the functionality of the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems. These tests have been performed to assess the functionality of the subject devices. The results of all conducted testing and clinical evaluation of images were found acceptable and did not raise any new issues of safety or effectiveness.
## 10. General Safety Concerns:
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device safely and effectively.
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SIEMENS Healthineers
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practices, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals who are trained and responsible for evaluating the post-processing of X-ray images.
11. Conclusion as to Substantial Equivalence:
The predicate devices were cleared based on non-clinical supportive information. Non-clinical test results demonstrate that the ARTIS genio floor / ARTIS icono.explore floor (VE50B) systems acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data, and software validation data demonstrates that the Subject Devices are as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use.
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