DigitalDiagnost

K210692 · Philips Medical Systems Dmc GmbH · KPR · Apr 2, 2021 · Radiology

Device Facts

• Record ID: K210692
• Device Name: DigitalDiagnost
• Applicant: Philips Medical Systems Dmc GmbH
• Product Code: KPR · Radiology
• Decision Date: Apr 2, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography

Device Story

DigitalDiagnost is a stationary digital radiography system for routine clinical imaging. System components include a height-adjustable patient support table, ceiling-suspended X-ray tube, and vertical stands. Input consists of X-ray radiation captured by a fixed flat-panel detector (Pixium 4343RCE) or portable wireless detectors (SkyPlates). The system uses a high-voltage generator and collimator to produce images, which are processed, stored, and viewed via the Eleva workstation. Operated by clinicians in clinical settings (e.g., trauma, ICU), the device provides digital images to assist in diagnostic decision-making. Modifications from the predicate include mechanical tube head controls, updated service logging features, and software version 42. The device facilitates patient care by enabling rapid, high-quality radiographic assessment.

Clinical Evidence

No clinical data. Bench testing only, including system verification, software verification, risk control, image quality, and usability engineering, performed per FDA-recognized standards (e.g., IEC 60601-1, IEC 60601-2-54, IEC 62304).

Technological Characteristics

Stationary X-ray system; Class II. Components: height-adjustable table, ceiling suspension, X-ray generator, Pixium 4343RCE fixed detector, SkyPlates wireless detectors. Connectivity: DICOM-compliant, networked for service logs/PerformanceBridge. Software: Eleva v42, Windows 10. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-54, IEC 62304.

Indications for Use

Indicated for patients requiring routine radiography examinations, including intensive care, trauma, or pediatric imaging. Contraindicated for fluoroscopy, angiography, and mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• DigitalDiagnost C90 (K202564)

Reference Devices

• CombiDiagnost R90 (K203087)

Submission Summary (Full Text)

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Philips Medical Systems DMC GmbH % Supriya Dalvi Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY

### Re: K210692

Trade/Device Name: DigitalDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB, LLZ Dated: March 3, 2021 Received: March 8, 2021

Dear Supriya Dalvi:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

April 2, 2021

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K210692

Device Name DigitalDiagnost

Indications for Use (Describe)

The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary of Safety and Effectiveness

| Preparation<br>Date: | March 3rd 2021 | | |
|----------------------|-----------------------------------------------|----------------------------------------------------------------|--|
| 510(k)<br>Owner: | Philips Medical Systems DMC GmbH | | |
| | Roentgenstrasse 24 | | |
| | 22335 Hamburg | | |
| | GERMANY | | |
| | Establishment registration number: 3003768251 | | |
| Contact: | Dr. Supriya A. Dalvi | | |
| | Regulatory Operations Specialist | | |
| | Phone: [phone] | | |
| | Fax: [phone] | | |
| | E-mail: [e-mail] | | |
| Proposed<br>Device | Device Name | DigitalDiagnost | |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| | Classification Name: | Stationary x-ray system | |
| | Classification Regulation: | 21 CFR 892.1680 | |
| | Classification Panel: | 90 - Radiology | |
| | Device Class: | Class II | |
| | Primary Product Code: | KPR | |
| | Secondary Product Codes: | MQB, LLZ | |
| Predicate<br>Device | Device Name | DigitalDiagnost C90 (K202564, cleared September<br>30th, 2020) | |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| | Classification Name: | Stationary X-Ray System | |
| | Classification Regulation: | 21 CFR Part 892.1680 | |
| | Classification Panel: | 90 - Radiology | |
| | Device Class: | Class II | |
| | Primary Product Code: | KPR | |
| | Secondary Product Codes: | MQB, LLZ | |
| Reference<br>Device | Device Name | CombiDiagnost R90 (K203087, cleared December 3rd,<br>2020) | |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH | |
| | Classification Name: | Image-intensified fluoroscopic x-ray System | |
| | Classification Regulation: | 21 CFR Part 892.1650 | |

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

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| Classification Panel: | 90 - Radiology | | |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II | | |
| Primary Product Code: | JAA | | |
| Secondary Product Codes: | KPR, MQB | | |
| Device Description: | The proposed DigitalDiagnost is a high-end digital radiography system consisting of a height adjustable patient support table and a ceiling suspension consisting of a tube including a control handle used to acquire images with a flat panel fixed RAD detector. Additionally, different vertical stands for the radiography examinations are available. The ceiling suspension can be moved in longitudinal and lateral directions and additionally the tube can be tilted and rotated as well. The system is configured with a Philips x-ray generator and a flat panel fixed RAD detector, Pixium 4343RCE. Together with the tube these components form the radiography Image Chain. The additional option of the portable wireless detector i.e. the SkyPlates family can be used for free exposures as well as in the patient support table or in the vertical stand.<br>The proposed DigitalDiagnost is a modification of the predicate device, DigitalDiagnost C90 (K202564). The modifications include change of colour of the table, stand and ceiling suspension; changes in ceiling suspension, service features and a software update. The changes related to the software updates and service features have been recently cleared in the reference device, CombiDiagnost R90 (K203087). | | |
| Indications for Use: | The DigitalDiagnost is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | | |
| Fundamental Scientific Technology: | The proposed DigitalDiagnost employs the same basic construction, fundamental scientific technology and workflow as the predicate device, DigitalDiagnost C90 (K202564) with regards to the functionality of all its components. It has the same high voltage generator, X-ray tube, Collimator, detectors, workstation (ELEVA) for images post-processing, storage and viewing.<br><br>The solid state imaging including the detector for proposed device are same as predicate device (K202564) having the same physical, functional and operational characteristics. Also, other image chain components like X-ray tube and generator, which are used for exposure characteristics and clinical performance evaluation remains same. Hence all the features and characteristics potentially influencing image quality are same as predicate device, in accordance to FDA guidance document 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, dated September 1, 2016'.<br><br>The changes with respect to the predicate device are mainly to accommodate users with a focused need for core functionality, some of the optional features of the predicate device have been replaced or modified to result in the proposed DigitalDiagnost. These changes do not affect the clinical or functional outcome of the device. The modifications have been evaluated per the ISO 14971 risk assessment. Design control and risk management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable. Refer Table 1 below for comparison of the technological characteristics of the proposed device and predicate device, DigitalDiagnost C90 | | |
| | Predicate device,<br>DigitalDiagnost C90<br>(K202564) | Proposed device,<br>DigitalDiagnost | |
| Legal<br>Manufacturer | Philips Medical Systems DMC GmbH | Identical | |
| Classification | Class II per 21 CFR 892.1680,<br>Product codes KPR, MQB LLZ | Identical | |
| Regulation<br>Name | Stationary X-ray system | Identical | |
| Class | II | Identical | |
| Review Panel | Radiology | Identical | |
| Indications<br>for Use | The DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. | Identical except updated trade name | |
| Principle of<br>Operation | DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. It is suitable for all routine radiography examinations, including specialist areas like intensive care, trauma or pediatric work, excluding fluoroscopy, angiography and mammography. The system consists of several components that can be combined to create a variety of different Xray configurations. | Identical | |
| Components | Height adjustable table (TH2) | Identical except color of table<br>(Change #1) | |
| | Single side suspended table (TH-S) | Identical except color of table<br>(Change #1) |…