ProxiDiagnost N90

K212837 · Philips Medical Systems Dmc GmbH · JAA · Sep 21, 2021 · Radiology

Device Facts

• Record ID: K212837
• Device Name: ProxiDiagnost N90
• Applicant: Philips Medical Systems Dmc GmbH
• Product Code: JAA · Radiology
• Decision Date: Sep 21, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ProxiDiagnost N90 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 is a floor-mounted, tilt-adjustable R/F system for routine radiography and fluoroscopy. Input: X-ray radiation captured by a Cesium Iodide flat panel detector (Pixium FE4343F). Operation: System includes a high-end digital radiography unit, X-ray generator, tube assembly, and Eleva Workspot workstation. The operator uses the workstation to preset exam data, process, store, and export digital images. The system supports standing, seated, or lying patient positions. Output: Digital radiographic and fluoroscopic images displayed on dual monitors. Clinical use: Used by clinicians in clinical settings to visualize anatomy for diagnostic decision-making. Benefits: Provides high-quality diagnostic imaging for various clinical procedures, including angiography and pediatric exams, with enhanced workflow features like remote control, bone suppression, and automated exposure indexing.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical performance testing, including system and sub-system verification, software verification, and adherence to recognized standards (e.g., IEC 60601-1, IEC 60601-2-54, ISO 14971).

Technological Characteristics

Multi-functional R/F system; floor-mounted tilt table (-85° to +90°); Cesium Iodide flat panel detector; high-voltage generator; X-ray tube; motorized collimator. Connectivity: Networked workstation (Eleva Workspot). Software: Windows 10, Eleva software (Increment 42). Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for routine radiography and fluoroscopy exams, including angiography and pediatric work, for patients in standing, seated, or lying positions. Excludes 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

• ProxiDiagnost N90 (K173433)

Reference Devices

• CombiDiagnost R90 (K203087)
• DigitalDiagnost C90 (K202564)

Submission Summary (Full Text)

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September 21, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K212837

Trade/Device Name: ProxiDiagnost N90 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, KPR Dated: September 3, 2021 Received: September 7, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Laurel M. Burk-S. The date of the signature is 2021.09.21, and the time is 14:29:22 -04'00'.

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) K212837

Device Name

ProxiDiagnost N90

#### Indications for Use (Describe)

ProxiDiagnost N90 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) | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary of Safety and Effectiveness

# K212837

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

| Preparation<br>Date: | September 3rd 2021 | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Owner: | Philips Medical Systems DMC GmbH<br>Roentgenstrasse 24<br>22335 Hamburg<br>GERMANY<br>Establishment registration number: 3003768251 | |
| Contact: | Dr. Supriya A. Dalvi<br>Regulatory Operations Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Proposed<br>Device | Device Name | ProxiDiagnost N90 |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH |
| | Classification Name: | Image-intensified fluoroscopic x-ray System |
| | Classification Regulation: | 21 CFR Part 892.1650 |
| | Classification Panel: | 90 – Radiology |
| | Device Class: | Class II |
| | Product Code: | JAA; KPR |
| Predicate<br>Device | Device Name | ProxiDiagnost N90 (K173433, February 5, 2018) |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH |
| | Classification Name: | Image-intensified fluoroscopic x-ray system |
| | Classification Regulation: | 21 CFR Part 892.1650 |
| | Classification Panel: | 90 – Radiology |
| | Device Class: | Class II |
| | Product Code: | OWB; JAA |
| Reference<br>Device # 1 | Device Name | CombiDiagnost R90 (K203087, December 3rd, 2020) |
| | Legal Manufacturer | Philips Medical Systems DMC GmbH |
| | Classification Name: | Image-intensified fluoroscopic x-ray System |
| | Classification Regulation: | 21 CFR Part 892.1650 |
| | Classification Panel: | 90 – Radiology |
| | Device Class: | Class II |
| | Product Code:…