ARTIS pheno

K163286 · Siemens Medical Solution USA, Inc. · OWB · Mar 9, 2017 · Radiology

Device Facts

• Record ID: K163286
• Device Name: ARTIS pheno
• Applicant: Siemens Medical Solution USA, Inc.
• Product Code: OWB · Radiology
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ARTIS is a family of dedicated angiography systems developed for single 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, 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. 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 Xray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family 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

ARTIS pheno is an interventional fluoroscopic X-ray system for diagnostic and surgical procedures. It utilizes a C-arm, X-ray tube, high-voltage generator, and Canon CSX-30 flat panel detector to acquire 2D X-ray images. The system supports DynaCT software for 3D reconstruction of 2D acquisitions. Operated by healthcare professionals in clinical or OR settings, the system features a motorized table, tableside control modules, and an optional anti-microbial coating. It processes images using advanced noise reduction, automated contrast/brightness adjustment, and spatial modulation transfer functions. Output is displayed on EIZO MX242W monitors to assist clinicians in surgical planning, interventional guidance, and treatment follow-up. The system integrates with navigation and ultrasound systems (ACUSON Freestyle). Benefits include improved patient positioning, higher load capacity, and enhanced image quality via 2k matrix imaging.

Clinical Evidence

Device safety and effectiveness were validated through non-clinical bench testing, including electrical safety (ES60601-1), EMC (60601-1-2), and software verification/validation (IEC 62304). Human factor usability validation was conducted with two representative user groups to ensure safety-relevant functions and warning comprehension. Clinical assessment was performed at two test sites (Frankfurt and Hannover) to confirm performance in intended use environments. No new safety or effectiveness issues were identified.

Technological Characteristics

System components: C-arm (100-130cm), Canon CSX-30 flat panel detector (2496x1856 pixels), X-ray tube, generator, and motorized table (up to 280kg). Connectivity: Profinet protocol for internal communication. Software: VE10 system software with integrated syngo VD20. Features: Anti-microbial coating, 2k image matrix, advanced noise reduction, and automated dose regulation. Standards: ES60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60825-1, 62304, 10993-1, 14971, 80001-1.

Indications for Use

Indicated for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography, rotational angiography, and whole-body radiographic/fluoroscopic procedures. Suitable for pediatric and obese patients. Used for image-guided surgery, image fusion, and navigation.

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

• Artis Q and Artis Q.zen - Modular Angiographic System (K123529)
• Artis zee/zeego with CSX-10 Detector SW VC21 (K122644)
• syngo Application Software (K162541)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2017

Siemens Medical Solution USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355

Re: K163286

Trade/Device Name: ARTIS pheno Regulation Number: 21 CFR 892.1650 Regulation Name: Interventional fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: February 10, 2017 Received: February 13, 2017

Dear Ms. 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 (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. 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 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163286

Device Name ARTIS pheno

### Indications for Use (Describe)

ARTIS is a family of dedicated angiography systems developed for single 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, 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.

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 Xray imaging, surgery and interventions.

ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

The ARTIS family 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary: ARTIS pheno

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355

February 10, 2017 Date Prepared:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

### 1. General Information: Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A 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 Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device Name and Classification:

| Trade Name: | ARTIS pheno |
|----------------------------|---------------------------------------------|
| Classification Name: | Interventional fluoroscopic X-Ray<br>System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1650 |
| Device Class: | Class II |
| Primary Product Codes: | OWB |
| Secondary Product Code: | JAA |

- Legally Marketed Primary Predicate Device 4. Trade Name: Artis Q and Artis Q.zen - Modular Angiographic System K123529 510(k) Clearance

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Clearance Date Classification Name:

Classification Panel: CFR Section: Device Class: Product Codes: Total Product Life Cycle: February 12, 2013 Interventional fluoroscopic X-Ray System Radiology 21 CFR §892.1650 Class II OWB, JAA, IZI 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.

Legally Marketed Secondary Predicate Device Trade Name:

510(k) Clearance Clearance Date Classification Name:

Classification Panel: CFR Section: Device Class: Product Code: Total Product Life Cycle:

Artis zee/zeego with CSX-10 Detector SW VC21 K122644 May 16, 2013 Interventional fluoroscopic X-Ray System Radiology 21 CFR §892.1650 Class II OWB Recall product incidents All are

considered during the Design Input phase of development to ensure the latest models will not be affected by any of the applicable issues.

### Legally Marketed Secondary Predicate Device

Trade Name: 510(k) Clearance Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Total Product Life Cycle: syngo Application Software K162541 November 16, 2016 System, Image processing, Radiological Radiology 21 CFR §892.2050 Class II LLZ There are no Recalls for this Predicate Device

#### 5. Device Description:

The ARTIS pheno is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.

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The following modifications are made to the cleared Artis Q and Artis Q.zen - Modular Angiography System, software version VD10 which created the Subject Device.

## Proposed Device Modifications:

- Newly designed C-arm and stand. 1)
- 2) Optional Anti-Microbial Coating on surface of C-arm, stand and table
- Newly designed table. 3)
- Newly designed tableside control modules (TCM) 4)
- 5) New Flat Panel detector Canon CSX-30
- Newly designed collimator for both angiography and cardiology 6)
- New System Software Version VE10 7)
- 8) Integration of the post-processing syngo Application Software VD20
- 9) Preparation for ACUSON Freestyle Elite w. Artis Access
- 10) Modified image processing
- 11) Modified dose regulation
- New Display EIZO MX242W 12)
- Modified Display Ceiling Suspension 13)
- 14) Proposed product claims associated with the above device modifications
- Updated 510(k) information 15)

The ARTIS pheno is substantially equivalent to the Artis Q and Artis Q.zen - Modular Angiography System VD10 with all its components as described in the Device Description, and the Substantial Equivalence sections.

#### 6. Indication for Use:

ARTIS is a family of dedicated angiography systems developed for single 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 multipurpose angiography and www.whole angiography, an body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

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.

ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

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The ARTIS family 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.

#### 7. Substantial Equivalence:

The ARTIS pheno is substantial equivalent to the legally marketed predicates listed in the table below:

| Predicate Device Name<br>and Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|--------------------------------------------------------------------------------------------|--------------------|--------------------------|-----------------------------------------------------------------------------------------|
| <b>Primary Predicate</b><br>Artis Q and Q.zen -<br>Modular Angiographic<br>System | K123529 | 02/12/2013 | • Indications for use<br>• System for Image Acquisition<br>• System for post processing |
| <b>Secondary Predicates</b><br>Artis zee/zeego<br>w/CSX10<br>syngo Application<br>Software | K122644<br>K162541 | 05/16/2013<br>11/16/2016 | • Detector CSX-10<br>• VD11 Post-Processing<br>Software Features |

### 8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

ARTIS pheno 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 different configurations to provide specialized angiography systems. Components used with ARTIS pheno are either commercially available with current Siemens systems or include modifications to existing components. Technological differences between the Subject Device and the Predicate Device is provided in the table below for all modifications.

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| Modification | Subject Device<br>ARTIS pheno<br>with SW VE10 | Predicate Device<br>Artis Q and Artis<br>Q.zen Modular<br>Angiography System<br>VD10 (K123529) | Comparison<br>Results |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Newly<br>designed C-<br>arm and stand | Stand with C-arm<br>diameter 100-130cm | Stand with C-arm<br>diameter 90-110cm | Increased C-arm<br>diameter for<br>steeper<br>angulations |
| Optional Anti-<br>Microbial<br>Coating on<br>surface of C-<br>arm, stand<br>and table | Surface of C-arm,<br>stand and table with<br>Anti-Microbial Paint<br>additive | Surface of C-arm, stand<br>and table without Anti-<br>Microbial Paint additive | Less risks of<br>infection due to<br>Anti-Microbial<br>Paint additive |
| Newly<br>designed<br>table | Improved patient table<br>up to 280kg / 617lbs<br>patient weight motor-<br>assisted longitudinal<br>and transversal travel<br>in leveled and tilted<br>position | Standard patient table<br>up to 250kg / 550lbs<br>patient weight motor-<br>assisted longitudinal<br>travel in tilted position | Improved patient<br>table due to<br>increased patient<br>load and higher<br>flexibility in<br>positioning |
| Newly<br>designed<br>tableside<br>control<br>modules | TCM (Table Control<br>Module)<br>PCM (Pilot Control<br>Module)<br>CCM (Collimator<br>Control Module)<br>Consolidation of<br>tableside controls<br>resulting in reduced<br>distance for operation<br>Hygienic optimization<br>due to sealed joysticks,<br>inner dead man<br>switches and less<br>corrugated gaiters. | TCM (Table Control<br>Module)<br>ECC (Examination<br>Control Console)<br>CCM (Collimator<br>Control Module) | Newly designed<br>with similar<br>functionality<br>Consolidation of<br>tableside controls<br>resulting in<br>reduced distance<br>for operation<br>Hygienic<br>optimization due<br>to sealed<br>joysticks, inner<br>dead man<br>switches and less<br>corrugated<br>gaiters. |
| New flat panel<br>detector<br>Canon CSX-<br>30 | CSX-30<br>2496 x 1856 pixels for<br>Live 2k imaging<br>1024 x 1024 pixels for<br>1k imaging<br>Input fields 50 cm, 42<br>cm, 32 cm, 22 cm, 16<br>cm, 11 cm | CSX-10<br>1792 x 1632 pixels<br>896 x 816 pixels with<br>2x2 binning<br>Input fields 39 cm, 32<br>cm, 26 cm, 20 cm, 16<br>cm, 10 cm | Similar resolution<br>with similar input<br>fields |
| Newly<br>designed<br>collimator for<br>both<br>angiography<br>and<br>cardiology | One collimator for both<br>angiography and<br>cardiology | One dedicated<br>angiography and one<br>dedicated cardiology<br>collimator | The newly<br>designed<br>collimator<br>combines the<br>functionality of<br>both the |
| | | | angiography and<br>cardiology |
| New Software<br>Version VE10 | Communication<br>platform for C-Arm,<br>table movements,<br>tableside control<br>modules, detector,<br>collimator, Integration<br>of the syngo<br>Application Software<br>VD20, image<br>processing, dose<br>processing via Profinet<br>protocol (industrial<br>standard) | Communication<br>platform for C-Arm,<br>table movements,<br>tableside control<br>modules, detector,<br>collimator, Interface to<br>the syngo Application<br>Software, image<br>processing, dose<br>processing via CAN<br>protocol (Controller<br>Area Network) | CAN protocol<br>(Controller Area<br>Network) has<br>changed to the<br>Profinet protocol<br>(industrial<br>standard) |
| Integration of<br>the post-<br>processing<br>syngo<br>Application<br>Software<br>VD20 | syngo Application<br>Software available on<br>ARTIS pheno PC<br>hardware | syngo Application<br>Software available on<br>separate syngo X<br>Workplace or on<br>separate PC hardware | Functionality of<br>syngo Application<br>Software<br>remains the same<br>and runs on one<br>PC hardware |
| Preparation<br>for ACUSON<br>Freestyle<br>Ultrasound<br>System<br>Artis<br>Freestyle<br>Access | Preparation for<br>ACUSON Freestyle<br>Ultrasound System<br>Artis Freestyle Access.<br>The interface will allow<br>for viewing of<br>ultrasound images at<br>the Large Display of<br>the Artis system | Preparation for<br>ACUSON Freestyle<br>Ultrasound System<br>Artis Freestyle Access<br>filed via NFJ. The<br>interface will allow for<br>viewing of ultrasound<br>images at the Large<br>Display of the Artis<br>system | Mechanical<br>adaptation for<br>ACUSON<br>Freestyle. Use of<br>existing interface<br>of the ARTIS<br>system |
| Modified<br>image<br>processing | -2k image matrix with<br>up to 15f/s<br>- Advanced noise<br>reduction algorithm<br>- Automated contrast<br>and brightness<br>adjustment<br>-spatial modulation<br>transfer function up to<br>16 frequency hands | -1k image matrix with<br>up to 15f/s<br>- noise reduction<br>algorithm<br>- Manual contrast and<br>brightness adjustment<br>(windowing)<br>--spatial modulation<br>transfer function up to 3<br>frequency bands | Increased image<br>matrix<br>More precise<br>control of the final<br>image<br>presentation |
| Modified Dose<br>regulation | constant signal to noise<br>ratio (image quality) | constant system dose<br>(entrance dose to the<br>detector) | Optimized<br>composition of X-<br>ray spectrum in<br>dependency of<br>water values |
| New Display<br>EIZO MX242W | Use of 24" display | Use of 19", 21", 22"<br>displays | Increased size of<br>display |
| Modified<br>Display<br>Ceiling<br>Suspension | DCS pivot mounted<br>DCS rail mounted | DCS rail mounted | Enhanced<br>positioning range |

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## SIER

### 9. Nonclinical Performance Testing:

Non-clinical tests were conducted for ARTIS pheno, during product development.

The ARTIS pheno was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the following standards for Electrical safety, performance and Electromagnetic Compatibility:

- ES60601-1:2005/(R)2012 ●
- 60601-1-2:2007 ●
- 60601-1-3:2008 ●
- 60601-1-6:2010/A1:2013
- 60825-1:2007 ●
- TR 60878:2015 ●
- 62304:2006 ●
- 80001-1:2010 ●
- 60601-2-28:2010 ●
- 60601-2-43:2010 ●
- 60601-2-54:2009/A1:2015
- 10993-1:2009
- 14971:2007 ●

All tests were passed.

The modifications described in this Premarket Notification were supported with verification and validation testing.

### Verification and Validation:

Software Documentation for a Major Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ARTIS pheno during product development.

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The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

ARTIS pheno was tested found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed safety relevant functions that need to be revalidated. Further risk mitigations have been defined in a corrective action plan to inform and train the current users of Artis pheno VE10. Users understanding of warnings were founded during testing. Warnings were updated in the documentation and the summative usability validation with two different samples of representative users was performed.

The ARTIS pheno VE10 has been found to be safe and effective for the intended users, uses and use environments, based on the results ascertained at the two clinical use test sites in Frankfurt and Hannover.

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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.

### Summary:

Performance tests were conducted to test the functionality of ARTIS pheno. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.

#### 10. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

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 practice, and all equipment is subject

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to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images.

### 11. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrrates that the ARTIS pheno acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, non-clinical performance data, clinical images and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that is currently marketed for the same intended use.