ProxiDiagnost N90 / Precision CRF (706110, 706400)

K233945 · Philips Medical Systems Dmc GmbH · JAA · Jan 11, 2024 · Radiology

Device Facts

• Record ID: K233945
• Device Name: ProxiDiagnost N90 / Precision CRF (706110, 706400)
• Applicant: Philips Medical Systems Dmc GmbH
• Product Code: JAA · Radiology
• Decision Date: Jan 11, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Device Story

ProxiDiagnost N90 / Precision CRF is a multi-functional general radiography/fluoroscopy (R/F) system. It utilizes a floor-mounted tilt-adjustable patient support table and a scan unit with an X-ray tube and a Pixium FE4343F Cesium Iodide flat panel detector. The system captures X-ray images for diagnostic visualization. Operated by clinicians in a clinical setting, the Eleva Workspot workstation allows for image acquisition, processing, storage, and export. The system supports various patient positions (standing, seated, lying). Output images are reviewed by healthcare providers to assist in clinical decision-making for routine diagnostic procedures. The device includes optional components like wireless portable detectors, ceiling suspensions, and vertical stands to enhance clinical utility.

Clinical Evidence

No clinical data submitted. Bench testing only, including system verification, software verification, cybersecurity testing, and image quality assessment per FDA-recognized consensus standards (e.g., IEC 60601 series, IEC 62220-1-3).

Technological Characteristics

Multi-functional R/F system; X-ray energy source; Cesium Iodide flat panel detector (Pixium FE4343F); floor-mounted tilt-adjustable table (-85° to +90°); Eleva Workspot workstation; Windows 10 OS; connectivity via DICOM; cybersecurity controls implemented; software level of concern: moderate.

Indications for Use

Indicated for routine radiography and fluoroscopy exams, including angiography and pediatric applications, excluding mammography. Suitable for patients in standing, seated, or lying positions.

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

• ProxiDiagnost N90 (K212837)

Submission Summary (Full Text)

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January 11, 2024

Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Manager Roentgenstrasse 24 Hamburg, Hamburg 22335 GERMANY

Re: K233945

Trade/Device Name: ProxiDiagnost N90 / Precision CRF (706110, 706400) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: December 14, 2023 Received: December 14, 2023

Dear Ming Xiao:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K233945

Device Name

ProxiDiagnost N90 / Precision CRF (706110, 706400)

#### Indications for Use (Describe)

ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding 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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## 510(k) Summary of Safety and Effectiveness

K233945

This 510(k) summary of safety and effectiveness is prepared in accordance with 21 CFR క్తి807.92.

| Preparation Date: | December 14th., 2023 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Philips Medical Systems DMC GmbH<br>Röntgenstrasse 24<br>22335 Hamburg, GERMANY<br>Establishment registration number: 3003768251 |
| Primary Contact: | Ming Xiao<br>Regulatory Affairs Manager Diagnostic X-Ray (DXR)<br>Phone: [phone]<br>E-mail: [e-mail] |
| Secondary Contact: | Shalin Dave<br>Head of Regulatory Affairs Diagnostic X-Ray (DXR)<br>Phone: [phone]<br>E-mail: [e-mail] |
| Proposed Device | |
| Device Name | ProxiDiagnost N90 / Precision CRF (706110, 706400) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH<br>Röntgenstrasse 24<br>22335 Hamburg, GERMANY |
| Classification Name: | Image-intensified Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR Part 892.1650 |
| Classification Panel: | 90 - Radiology |
| Device Class: | Class II |
| Classification Product Code: | JAA |
| Subsequent Product Code: | KPR |
| Predicate Device | |
| Device Name | ProxiDiagnost N90 (K212837, September 21, 2021) |
| Legal Manufacturer | Philips Medical Systems DMC GmbH<br>Röntgenstrasse 24<br>22335 Hamburg, GERMANY |
| Classification Name: | Image-intensified Fluoroscopic X-ray System |
| Classification Regulation: | 21 CFR Part 892.1650 |
| Classification Panel: | 90 – Radiology |
| Device Class: | Class II |
| Classification Product Code: | JAA |
| Subsequent Product Code: | KPR |

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## Device Description

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, Substantial Equivalent (SE) date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a multi-functional general Radiography/ Fluoroscopy (R/F) system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF is a nearby controlled fluoroscopy system in combination with high-end digital radiography system consisting of a floor-mounted tilt adjustable patient support table and a scan unit consisting of a tube and a flat panel dynamic detector, Pixium FE4343F, for the fluoroscopy examinations. The tabletop can be moved by a motor in the lateral and longitudinal direction and can be tilted at -85° to +90° degrees. The scan unit tilts with the table and can be moved in the longitudinal and lateral direction, relative to the table and to the patient. The system is suitable for routine X-ray examinations and fluoroscopy examinations on patients in standing, seated, or lying positions. Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF retrieves images by means of a Cesium Iodide flat panel detector.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the proposed ProxiDiagnost N90 / Precision CRF consists of the Basic unit ("geometry" or "table unit"), Workstation Eleva Workspot (with integrated generator control, hand switch, keyboard, mouse, touch screen and PC), dual screen-monitor, Spot film device (digital camera or flat panel detector). Fixed Detector (Fluoroscopy). X-ray Generator for R/F applications, X-ray tube assembly. The optional components like wireless portable detectors small and large, Bucky tray for wireless portable detectors SkyPlate detector, Ceiling Suspension, Fixed Vertical stand, Ceiling Suspension for monitors, monitor trolley, Remote control for R/F (Radiography-fluoroscopy) viewer, accessories for "Stitching Stand", are also available.

Same as the legally marketed predicate device ProxiDiagnost N90 (K212837, SE date on September 21, 2021), the Eleva software of the proposed ProxiDiagnost N90 / Precision CRF is based on a workstation i.e., Eleva Workspot (computer, keyboard, display, and mouse) that is used by an operator to preset examination data and to generate, process and handle digital x-ray images. The Eleva Software system is decomposed into software components. These components are clustered in three component collections like the image handling focused Backend (BE), the acquisition focused Front-end (FE) and Image Processing (IP). The Eleva software is intended to acquire, process, store, display and export digital fluoroscopy and radiographic images.

The accessories for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the accessories for the proposed ProxiDiagnost N90 / Precision CRF:

- Footrest ●
- Hand Grips 0

Radiation Protection Accessories

- Flexible Radiation Protection Apron 0

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- Front Radiation Protection Apron ●
Additional Accessories (Optional)

- Monitor Trolley ●
- Monitor Ceiling Suspension
- Parking Frame for Accessories ●
- Shoulder Support ●
- Side bar ●
- Compression Belt ●
- Adjustable Lateral Cassette Holder
- Leg Supports
- o Infusion Bottle Holder
- Arm Support for Catheterization
- Ankle Clamps
- Overhead Hand Grip
- Adult Headrest
- Mattress
- Rotatable Stool for Footrest
- Pediatric Micturition Set
- Stretch Grip for Wall Stand
- Bar Code Scanner o
- Patient Support ●
- o Stitching Ruler

Accessories for the SkyPlate Detector (Optional)

- Mobile Detector Holder ●
- Detector Holder Patient Bed ●
- Portable Panel Protector ●
- Detector Handle ●
- WPD Bags ●
- o Grids for SkyPlate Detector large

The Components for the proposed ProxiDiagnost N90 / Precision CRF are the same as the predicate device ProxiDiagnost N90 (K212837).

The list of the Components for the proposed ProxiDiagnost N90 / Precision CRF:

- Eleva Workspot and RF Viewer ●
- UPS for Eleva Workspot (Optional) ●
- Table ●
- Indication Box ●
- Foot Switch
- Ceiling Suspension Motorized CSM3 (Optional) ●
- Wall Stand (Vertical Stand VS2) (Optional)
- SkyPlate / Portable Detector (Optional) 0

The proposed device complies to 'Guidance for the Submission of 510(k)'s for Solid State Xray Imaging Devices, dated September 1, 2016'. The solid-state imaging components including the detector in the proposed device have the same physical, functional, and operational characteristics as the predicate device (K212837). Also, other image chain components like Xray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains the same. Hence all the features and characteristics potentially influencing

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image quality of the proposed are in accordance with FDA guidance document. Additionally, image quality testing has been performed on the proposed device for the changes that are affecting the image quality.

### Indication for Use:

ProxiDiagnost N90 / Precision CRF is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

## Comparison to Predicate Device / Design Changes Summary:

The proposed ProxiDiagnost N90 / Precision CRF uses the same workflow as the predicate device ProxiDiangost N90 (K212837) with only the following modifications. Differences on the proposed device with respect to the predicate device ProxiDiagnost N90 (K212837) are as follows:

- 1) Change #1: Modifications to System Software Baseline upgrade releases for ProxiDiagnost N90
- Release Version R1.1.0 was internally released only, never released a) for production, based on predicate device ProxiDiagnost N90 (K212837)
- b) Release Version R1.1.1 was released based on design changes on Software updates
- c) Release Version R1.1.2 was aborted
- Release Version R1.1.3 is for proposed device ProxiDiagnost N90 d) per current submission

The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.

# 2) Change #2: Modifications to Ceiling Suspension Motorized (CSM/CSM3)

This is an optional component for radiography examinations only.

- a) Replacing the Beta rotation lock mechanism parts
- b) Introduction of dual sourcing for CSM/CSM3 Tube mounts
- c) Improvements for Metallic Flakes CS Telescopic End Cover Kit

The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 3) Change #3: Modifications to Wall Stand (VS2)

- a) Replacing the Adapter parts for Bucky Unit 2
- b) Update VS2 combined family label
- c) VS2 Firmware change from FW 10.01.09 to FW 10.01.10 Version

The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 4) Change #4: Modifications to Patient Table

- a) Improvement on cable sleeve material
- b) Replacing SGCU PCBA parts
- c) Improvement on under table Collimator
- d) Changes in the M shield
- Replacing the Emergency stop switch e)

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The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.

## 5) Change #5: Modification to Monitor ceiling suspensions (MCS)

a) Introduction of Ceiling Connection Box for MCS

The modification has no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 6) Change #6: Modifications to accessory and components

- a) Replacing the Motor Gear Drive
- b) Replacing the Microcontroller IC for Bucky Unit family
- c) Replacing the Power Supply boards PCBAs

The modifications have no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 7) Change #7: Serviceability features: Introduction of Service parts for PC AWS-DI

The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 8) Change #8: Modification to subsystem detector Pixium 4343RCE2

This change was necessitated by the supplier's discontinuation of the detector model Pixium 4343RCE used in predicate device ProxiDiagnost N90 (K212837). The key parameters like pixel size, pixel array, scintillator and readout mechanism remain unchanged.

The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### 9) Change #9: Software Package 1.0.1 for Precision CRF

The change has no impacts on product safety, Intended Use, effectiveness, functionality and performance.

### Fundamental Scientific Technology:

The proposed ProxiDiagnost N90 / Precision CRF is substantially equivalent to the manufacturer's legally marketed devices:

- Predicate Device: ProxiDiagnost N90, (K212837, SE date September 21, 2021), Philips . Medical Systems DMC GmbH
A detailed comparison of the proposed and predicate device (K212837) is provided in Table 1.

Design control activities for each change identified along with associated verification. validation, and risk mitigation activities performed to ensure that the proposed modifications do not affect device safety and / or effectiveness.

| | Predicate Device,<br>ProxiDiagnost N90 (K212837) | Proposed Device,<br>ProxiDiagnost N90 / Precision CRF |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Legal Manufacturer | Philips Medical Systems DMC GmbH<br>Röntgenstrasse 24<br>22335 Hamburg<br>Germany | Identical |
| | Predicate Device,<br>ProxiDiagnost N90 (K212837) | Proposed Device,<br>ProxiDiagnost N90 / Precision CRF |
| Classification | Class II per 21 CFR Part 892.1650,<br>Primary Product code: JAA<br>Secondary Product code: KPR | Identical |
| Regulation Name | Stationary x-ray system | Identical |
| Class | II | Identical |
| Review Panel | Radiology | Identical |
| Indications for Use | ProxiDiagnost N90 is a multi-functional<br>general R/F system. It is suitable for all<br>routine radiography and fluoroscopy<br>exams, including specialist areas like<br>angiography or pediatric work, excluding<br>mammography. | ProxiDiagnost N90 / Precision CRF is a<br>multi-functional general R/F system. It is<br>suitable for all routine radiography and<br>fluoroscopy exams, including specialist<br>areas like angiography or pediatric work,<br>excluding mammography.<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Energy Source | X-ray | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Principle of<br>Operation | ProxiDiagnost N90 systems are intended<br>for the medical application procedures for<br>fluoroscopy and Radiography. ProxiDiag-<br>nost N90 systems allow radiography (with<br>optional 2nd Tube on Ceiling suspension)<br>and fluoroscopy on a patient in supine,<br>seated or standing position, depending on<br>the specific indication. Depending on the<br>specific indication, X-ray procedures vary<br>in patient positioning and the modification<br>of radiographic parameters | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Table Features | | |
| Working height<br>(tabletop center to<br>floorplate) | 833 mm | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Table tilt movement | +90° to -85°<br>Speed of tilt $ < 1°/s $ to $ 6°/s $ | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Tabletop suspension | Two sides suspensions | Identical |
| | Predicate Device, ProxiDiagnost N90 (K212837) | Proposed Device, ProxiDiagnost N90 / Precision CRF |
| Tabletop material | Sandwich of laminate, carbon, and foam | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Tabletop movement | Transversal-100 mm to +90 mm<br>Longitudinal: Maximum ±835 mm | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Tabletop absorption | 0.6mm Al typical @ 100kV | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Maximum patient weight | static: 300 kg<br>tilt: 250 kg<br>all movements: 185 kg | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Lateral scan distance | 220 mm | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Lateral scan speed | Manual Movement | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Longitudinal scan distance | 750 mm | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Source image distance | 810 mm to 1,300 mm | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| <b>Other Components</b> | | |
| Generator | Philips Velara GCF/RF, 65 kW, optional 80 kW | Identical for ProxiDiagnost N90<br>For Precision CRF, only 80 kW is applicable.<br>Equivalent; No impact to safety and effectiveness of the device. |
| Tube | Philips SRM 2250 ROTGS 504 or SRO 2550 ROT380 | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Fixed Detector (Fluoroscopy) | Pixium FE 4343F | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Modulation Transfer Function (MTF) (according to IEC 62220-1-3 standard) | lp/mm %<br>1 66<br>2 35<br>3 19<br>3.4 15 | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Detective Quantum Efficiency (DQE) | DQE at 1 μGy<br>lp/mm % | Identical |
| | Predicate Device,<br>ProxiDiagnost N90 (K212837) | Proposed Device,<br>ProxiDiagnost N90 / Precision CRF |
| (according to IEC<br>62220-1-3 standard) | 0.05<br>1<br>2<br>3<br>3.4<br>65<br>51<br>41<br>27<br>18 | Equivalent; No impact to safety and<br>effectiveness of the device. |
| System Control | Nearby | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Collimator<br>(Fluoroscopy) | Rectangular collimation | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Grid | Parkable | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Picture archiving<br>and communication<br>system | Available | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Extended reviewing options | | |
| Remote Control | Infrared remote control for Image<br>Navigation | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Reference monitor<br>(Optional) | Additional monitor for reference image<br>support [Change #1b] is available.<br>The additional reference monitor is made<br>available for the display of a reference<br>image in the Examination Room and<br>optionally in Control Room. | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Image processing | | |
| Image processing functionality | | |
| DSA (Digital<br>Subtraction<br>Angiography)<br>(Optional) | Digital Subtraction Angiography<br>functionality is available. It is used for<br>angiography and provides interactive<br>viewing operations on a vascular run, so<br>that the vascular anatomy becomes visible. | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Predefined<br>annotations<br>integrated into the<br>dynamic viewer | Predefined annotations are available which<br>enables the user to assign annotation to the<br>image with the help of a set of predefined<br>annotations. This speeds the user<br>workflow. | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Image processing functionality | | |
| Bone Suppression<br>(Optional) | Bone Suppression post-processing<br>application is available. It is intended to | Identical for ProxiDiagnost N90<br>Bone suppression is not applicable for<br>Precision CRF |
| | Predicate Device,<br>ProxiDiagnost N90 (K212837) | Proposed Device,<br>ProxiDiagnost N90 / Precision CRF |
| | image of the chest by suppressing bones from the original image. | Equivalent; No impact to safety and effectiveness of the device. |
| UNIQUE | Dynamic UNIQUE (fluoroscopy modality only)- no change UNIQUE 2 (radiography modality only) | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Intuitive User<br>Interface for<br>Processing<br>Parameters | An intuitive way of modifying the available parameters is introduced (e.g., contrast, brightness, noise limit, detail enhancement etc.) on the Eleva user interface. | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Deviation and<br>Target Exposure<br>Indices | Deviation Index (DI) function is available to quantify the deviation of the Exposure Index (EI s) from the Target Exposure Index (EI T). This feature is used by the clinical user only to identify whether a certain image has been correctly exposed. | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| SkyFlow (Optional) | Skyflow is extended to imaging of other anatomies (e.g., Leg, hand etc.) including the chest AP/PA imaging, with Skyplate detector. | Identical for ProxiDiagnost N90<br>SkyFlow is not applicable for Precision CRF.<br>Equivalent; No impact to safety and effectiveness of the device. |
| Access to and<br>Export of Original<br>Image Data | Access to and Export of Original Image Data feature enables the access to an export of original image data (clean raw images without any modification) on the system. | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| One Button Stores<br>All (OBSA):<br>Content and<br>performance<br>Improvement | System can additionally use OBSA for sending logfile (Alert files) to central database (RSN, e.g., RADAR or M2M server) frequently by single button click. | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| View Selection for<br>Changed X-Ray<br>Generation Data<br>Sets | Users can change a data set only for current examination or the examinations that are using this data set.<br>In addition to the current examinations, the user can select to apply the changes to subset of all examinations too that are using this data set. | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| Avoid Ghosting in<br>Verification Images<br>of Portable<br>Detectors | The feature to avoid ghosting in verification images of portable detectors is available. It enables the system to display verification images on wireless (SkyPlate) detector without ghosting artifacts | Identical<br>Equivalent; No impact to safety and effectiveness of the device. |
| | Predicate Device,<br>ProxiDiagnost N90 (K212837) | Proposed Device,<br>ProxiDiagnost N90 / Precision CRF |
| Software | | |
| Operating System | Windows 10 | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Image Chain<br>(fluoroscopy) | Philips Dynamic Eleva Image Chain | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Image acquisition | Eleva Workspot (Increment 42) | Identical<br>Eleva Workspot (Increment 42.3) is<br>applicable for ProxiDiagnost N90.<br>Eleva Workspot (Increment 42.2) is<br>applicable for Precision CRF.<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| | Ceiling Suspension (optional) for Radiography examinations only | |
| Type | Four-part aluminum telescopic column<br>with spring counter balanced holder for X-<br>ray tube assembly; adaptable to individual<br>room heights | Identical<br>Equivalent; No impact to safety and<br>effectiveness of the device. |
| Movement | 3440 mm to 6140 mm…