Philips CombiDiagnost R90

K163210 · Philips Medical Systems Dmc GmbH · JAA · Jan 31, 2017 · Radiology

Device Facts

• Record ID: K163210
• Device Name: Philips CombiDiagnost R90
• Applicant: Philips Medical Systems Dmc GmbH
• Product Code: JAA · Radiology
• Decision Date: Jan 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

CombiDiagnost R90 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

CombiDiagnost R90 is a remote-controlled, floor-mounted, tilt- and height-adjustable fluoroscopy and digital radiography system. It utilizes an X-ray tube, collimator, and Pixium FE 4343F flat panel detector to capture radiographic and fluoroscopic images. Operated by physicians or technicians in hospital settings, the system features motorized table movements, automatic collimation, and pre-positioning capabilities. The device integrates with the Philips Dynamic Eleva Image Chain for image acquisition and processing. Output is displayed on high-resolution monitors for clinical review, supporting diagnostic decision-making across general, pediatric, and interventional applications. The system enhances workflow through remote control and motorized positioning, benefiting patients by enabling efficient, versatile imaging in various positions (recumbent, standing, seated).

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing, including software validation and image quality assessment per international consensus standards (ISO 14971, IEC 60601 series, IEC 62304, IEC 62220-1).

Technological Characteristics

Floor-mounted X-ray system with motorized tilt/height-adjustable table. Materials: plastic laminate/carbon fiber tabletop. Components: Philips generator (65kW/80kW), Philips X-ray tubes, Pixium FE 4343F flat panel detector. Connectivity: DICOM-compatible PACS integration. Software: Philips Dynamic Eleva Image Chain. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, IEC 62220-1, IEC 62304, ISO 14971.

Indications for Use

Indicated for routine radiography and fluoroscopy exams, including angiography and pediatric applications, in patients requiring diagnostic imaging. Contraindicated for mammography.

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

• Philips EasyDiagnost Eleva (K031535)

Reference Devices

• Eleva Workspot with SkyFlow (K153318)
• Pixium FE 4343F (K080859)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing to the right.

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

January 31, 2017

Philips Medical Systems DMC GmbH % Ming Xiao Regulatory Affairs Specialist North America Roentgenstrasse 24-26 Hamburg, 22335 GERMANY

Re: K163210 Trade/Device Name: CombiDiagnost R90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, KPR and MQB Dated: January 17, 2017 Received: January 25, 2017

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 (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) K163210

Device Name CombiDiagnost R90

Indications for Use (Describe)

CombiDiagnost R90 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 7. 510(k) Summary

### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date Prepared: | January 26, 2017 | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer: | Philips Medical Systems DMC GmbH<br>Roentgenstrasse 24-26<br>22335 Hamburg<br>GERMANY<br>Establishment registration number: 3003768251 | | |
| Primary Contact<br>Person: | Ming Xiao<br>Regulatory Affairs Specialist<br>North America<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Device Name: | CombiDiagnost R90 | | |
| Classification: | Classification Name: | Image-intensified fluoroscopic x-ray<br>system | |
| | Classification Regulation: | 21CFR 892.1650 | |
| | Classification Panel: | 90 -- Radiology | |
| | Device Class: | Class II | |
| | Primary Product Code: | JAA | |
| | Secondary Product Codes: | KPR, MQB | |
| Primary Predicate<br>Device: | Trade Name: | Philips EasyDiagnost Eleva | |
| | Manufacturer: | Philips Medical Systems DMC | |
| | 510(k) Clearance: | K031535 – June 17, 2003 | |
| | Classification Name: | Image-intensified fluoroscopic x-ray<br>system; Stationary x-ray system; Spot-<br>film device; Tilting Radiographic table | |
| | Classification Regulation: | 21CFR 892.1650; 21CFR 892.1680;<br>21CFR 892.1670; 21CFR 892.1980 | |
| | Classification Panel: | Radiology | |
| | Device Class: | Class II | |
| | Product Codes: | JAA, KPR, IXL and IXR | |
| Reference Device: | Trade Name: | Eleva Workspot with SkyFlow | |
| | Manufacturer: | Philips Medical Systems | |
| | 510(k) Clearance: | K153318 – Dec 22, 2015 | |
| | Classification Name: | Stationary X-Ray System | |
| | Classification Regulation: | 21CFR 892.1680 | |
| | Classification Panel: | 90 -- Radiology | |
| | Device Class: | Class II | |
| | Product codes: | MQB, LLZ | |

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Device The CombiDiagnost R90 is a multi-functional remote controlled Description: fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.

Indications for CombiDiagnost R90 is a multi-functional general R/F system. It is Use: suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

Fundamental R90 is a multi-functional remote controlled CombiDiagnost Scientific fluoroscopy system in combination with high-end digital radiography Technology: consisting of a floor-mounted tilt- and height-adjustable patient -

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support and a scan unit consisting of a tube and a flat detector. It is designed for fluoroscopy examinations of the recumbent, standing or seated patient and also for lateral exposures. Fine positioning of the tube and collimator on the patient is easy to carry out using control grips and control buttons on table or tube user interfaces. It is quite convenient to be operated in hospitals. CombiDiagnost R90 is intended for use in generating radiographs of human anatomy by qualified/trained doctors or technicians. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

Based on the information provided above, the CombiDiagnost R90 is considered substantially equivalent to the primary currently marketed and predicate device EasyDiagnost Eleva (K031535, June 17, 2003) in terms of fundamental scientific technology.

This modified device has the same indications for use and Summary of technological characteristics as the primary predicate device, technological Eleva. Comparisons of the technological characteristics: EasyDiagnost characteristics demonstrate the substantial equivalence to the primary predicate device.

| | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>CombiDiagnost R90<br>(K163210) | Discussion |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table Features | | | |
| Working height<br>(table top center to<br>floorplate) | 83cm | 62 cm – 142 cm | Similar; the range of working<br>height does not affect the<br>safety or effectiveness of the<br>device. |
| Table tilt<br>movement | -20° to +90°<br>Optional:<br>-30° to +90°<br>-45° to +90°<br>-85° to +90° | -90° to +90° | Similar: The table tilt<br>movement does not affect the<br>safety or effectiveness of the<br>device. |
| Table top<br>suspension | Back and sides | Two sides suspensions | Similar: Two side table side<br>suspension does not affect the<br>safety or effectiveness of the<br>device. |
| Table top material | Plastic laminate or carbon<br>fiber | Same | Equivalent. |
| Table top<br>movement | Lateral: -10 cm to + 9 cm<br>Longitudinal: ± 83 cm | Same | Equivalent |
| Table top<br>absorption | 0.7mm typical (@ 100kV,<br>2.7mm Al HVL) | Plastic, with Carbon fiber:<br>0.6mm Al @ 100kV,<br>HVL = 3.6mm Al | Similar: Minor differences in<br>the table top absorption does<br>not affect the safety or<br>effectiveness of the device. |
| Maximum patient<br>weight | 180 kg | 284 kg (626 lbs) | The proposed CombiDiagnost<br>R90 is able to hold more |
| | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>CombiDiagnost R90<br>(K163210) | Discussion |
| | | | patient weight; this does not<br>affect the safety or effective-<br>ness of the device. |
| Lateral scan<br>distance | 22 cm | 32 cm ± 16 cm | Similar: The range of lateral<br>scan distances provided with<br>the proposed CombiDiagnost<br>R90 does not affect the safety<br>or effectiveness of the device. |
| Lateral scan speed | Manual Movement | 5 cm/s, soft start and stop<br>Auto centering | The automated lateral scan<br>speed provided with the<br>proposed CombiDiagnost R90<br>does not affect the safety or<br>effectiveness of the device. |
| Longitudinal scan<br>distance | 75 cm | 160 cm longitudinal,<br>motorized | Similar: The extended<br>longitudinal motorized scan<br>distance of the proposed<br>CombiDiagnost R90 does not<br>affect the safety or effective-<br>ness of the device. |
| Longitudinal scan<br>speed | Manual Movement (Servo<br>Support) | 3 cm - 20 cm / sec | Similar: The longitudinal scan<br>speed provided with the<br>proposed CombiDiagnost R90<br>does not affect the safety or<br>effectiveness of the device |
| Table column<br>angulation | N/A | -40° to +40° | The table angulation provided<br>with the proposed<br>CombiDiagnost R90 does not<br>affect the safety or effective-<br>ness of the device. |
| Source image<br>distance | 73cm - 103cm,<br>88cm - 118cm with Geomat<br>in extended position | 113cm - 183cm | Similar: The source image<br>distance provided with the<br>proposed CombiDiagnost R90<br>does not affect the safety or<br>effectiveness of the device. |
| Collimator | Square / rectangular plus<br>Iris | Motorized automatic<br>collimation | The motorized collimator<br>provided with the proposed<br>CombiDiagnost R90 does not<br>affect the safety or<br>effectiveness of the device. |
| Preparation time<br>for exposure | 0.4 - 1.8 sec (depends on X-<br>ray Tube and technique) | 1 sec (approximately) | Similar: The minor difference<br>in the preparation time does<br>not affect the safety or<br>effectiveness of the device. |
| Grid | Parkable | Same | Equivalent: No effect on the<br>safety or effectiveness of the<br>device. |
| Auto Grid<br>Selection | Yes | Same | Equivalent: No effect on the<br>safety or effectiveness of the<br>device. |
| Automatic pre-<br>position of the<br>table | No | Yes | The automatic pre-position of<br>the table provided with the<br>proposed CombiDiagnost R90<br>does not affect the safety or<br>effectiveness of the device. |
| | Primary Predicate Device:<br>EasyDiagnost Eleva<br>(K031535) | Proposed Device:<br>CombiDiagnost R90<br>(K163210) | Discussion |
| Picture archiving<br>and<br>communication<br>system | Yes | Same | Equivalent: No effect on the<br>safety or effectiveness of the<br>device. |
| Image chain<br>(fluoroscopy) | Philips Image Intensifier /<br>CCD TV / Digital Imaging | Philips dynamic Eleva<br>Image Chain | The proposed<br>CombiDiagnost R90 includes<br>the cleared Philips Eleva<br>WorkSpot of the reference<br>device (K153318) as part of<br>the image chain. Therefore,<br>no effect on the safety or<br>effectiveness of the device |
| Detector | Image Intensifier 23 cm, 31<br>cm or 38 cm | Pixium FE 4343F (cleared<br>via K080859 – Villa<br>Sistemi Medicali S.p.A.) | No impact on the safety or<br>effectiveness of the device.<br>The detector data is from the<br>reference device Philips<br>Eleva WorkSpot (K153318) |
| Generator | Philips Velara RF 50kW,<br>65kW or 80kW | Philips Velara 65kW,<br>optional 80 kW | Equivalent; The proposed<br>CombiDiagnost R90 uses a<br>Philips generator that<br>operates in the same manner. |
| Tube | Philips SRO 2550 or SRM<br>2250 GS | Philips SRO 33100 ROT<br>380 or SRM 0608 ROT<br>GS 505 | Equivalent; The proposed<br>CombiDiagnost R90 uses<br>Philips tubes that operate in<br>the same manner. |
| System Control | Near by | Remote | The proposed<br>CombiDiagnost R90 uses a<br>remote system control. This<br>does not affect the safety and<br>effectiveness. |
| Indications for<br>Use | The Philips EasyDiagnost<br>Eleva intended use is for the<br>following applications: As a<br>multi-functional/ universal<br>system, general R/F, Fluoro-<br>scopy, Radiography and<br>Angiography can be<br>performed along with<br>pediatric examinations and<br>some more specialized<br>interventional applications. | CombiDiagnost R90 is a<br>multi-functional general<br>R/F system. It is suitable<br>for all routine radiography<br>and fluoroscopy exams,<br>including specialist areas<br>like angiography or<br>pediatric work, excluding<br>mammography. | Equivalent; The Indications<br>for Use for the proposed<br>CombiDiagnost R90 is more<br>general in nature. |

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This 510(k) premarket notification contains technical documentation Summary of Non-Clinical which includes non-clinical verification and validation tests as well as image quality testing. Tests were performed on the proposed Data: CombiDiagnost R90 according to the following international and FDArecognized consensus standards:

- ISO 14971, Medical devices. Application of risk management to . medical devices
- · IEC 60601-1, Medical electrical equipment. General

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requirements for safety. Collateral standard. Safety requirements for medical electrical systems

- . IEC 60601-1-2. Medical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
- 60601-1-3. Medical equipment. IEC General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
- 60601-2-54, Medical electrical equipment. IEC Particular requirements for the basic safety and essential performance of Xray equipment for radiography and radioscopy
- . IEC 62220-1. Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency
- IEC 62304, Medical device software. Software life-cycle ● processes

The test results demonstrate that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use.

Based upon the same intended use, similar technology, software functionalities, same product configuration and administration, and similarity of materials, it can be concluded the proposed CombiDiagnost R90 is substantially equivalent to the primary predicate device EasyDiagnost Eleva, in terms of intended use, design characteristics, and safety and effectiveness.

Summary of The proposed CombiDiagnost R90 did not require a clinical study since Clinical Data: substantial equivalence to the currently marketed and predicate device was demonstrated with the following attributes:

- . Design features;
- Indication for use;
- . Fundamental scientific technology;
- Non-clinical performance testing including validation; and ●
- . Safety and effectiveness.

Substantial comparison of technological characteristics, non-clinical The Equivalence performance data, safety testing, software validation, and clinical image Conclusion: concurrence data demonstrates that the device is as safe and effective as the predicate device. Philips Medical Systems concludes that the proposed CombiDiagnost R90 is substantially equivalent to the legally marketed primary predicate device, EasyDiagnost Eleva.