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CombiDiagnost R90

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 709030510(k) K203087

by Philips Medical Systems DMC GmbH

Identity

Trade Name
CombiDiagnost R90 EUDAMEDFDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
Remote DRF-Systen EUDAMED
Image-intensified fluoroscopic x-ray system FDA UDI
Model / Reference
709030 EUDAMEDFDA UDI
Description
Image-intensified fluoroscopic x-ray system FDA UDI

Identifiers

Catalog Number
709030 FDA UDI
Primary DI / UDI-DI
00884838076747 EUDAMEDFDA UDI
Basic UDI-DI
B-00884838076747 EUDAMED
FDA Product Code
JAA FDA UDI
EMDN Code
Z11039009 FLUOROSCOPY DEVICES EUDAMED
GMDN Term
Stationary basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

The CombiDiagnost R90 Remote DRF System (Nomenclature Code: Z11039009) is a remote-controlled fluoroscopy system integrated with high-end digital radiography. It is designed for fluoroscopic and radiographic imaging applications, enabling versatile use across pediatric to bariatric patient sizes. The device combines digital radiography with fluoroscopy capabilities to enhance procedural efficiency and image quality.

This system is non-sterile, non-reusable, and non-implantable, intended for use in radiology settings. It operates with a fully digital workflow and includes dose management features to optimize imaging safety. Supplied as a single-use or reusable component system (Reference: 709030), it is regulated under FDA 510(k) clearance and MDD compliance. The device carries a UDI (Basic UDI: B-00884838076747) and is classified as Class IIb under regulatory frameworks.

Frequently asked questions

What types of imaging procedures can the CombiDiagnost R90 support, and how does its design accommodate different patient sizes?

The CombiDiagnost R90 is designed for both fluoroscopic and radiographic imaging, combining digital radiography with remote-controlled fluoroscopy to improve procedural efficiency and image clarity. Its versatile design allows it to be used across a wide range of patient sizes, from pediatric to bariatric, ensuring adaptability for diverse clinical needs.

Is the CombiDiagnost R90 system reusable, and if not, how is it supplied for use in clinical settings?

The CombiDiagnost R90 is not reusable (as indicated by the `REUSABLE: 0` field). It is supplied as part of a system (Reference: 709030) that can include both single-use and reusable components, depending on the specific configuration. The system itself is non-sterile and intended for use in radiology settings, with dose management features to optimize imaging safety.

What regulatory pathways does the CombiDiagnost R90 follow, and how does this affect its use in clinical practice?

The CombiDiagnost R90 is regulated under FDA 510(k) clearance (Traditional pathway, Class IIb) and MDD compliance, meaning it has undergone evaluation for safety and performance by regulatory authorities. This clearance ensures the device meets established standards for fluoroscopy and digital radiography systems, allowing clinicians to rely on its design and functionality for procedural imaging.

Does the CombiDiagnost R90 require sterilization, and if not, what precautions should be taken during handling?

The CombiDiagnost R90 is explicitly non-sterile (`STERILE: 0`). Since it is not intended for sterile procedures (e.g., surgical implantation), standard radiology hygiene practices—such as hand hygiene, surface disinfection, and adherence to manufacturer cleaning guidelines—should be followed to prevent contamination. Reusable components (if applicable) must be processed according to facility protocols for reprocessing medical devices.

How does the CombiDiagnost R90 support radiation safety during imaging procedures?

The system includes dose management features to optimize imaging safety, helping clinicians balance diagnostic quality with minimizing patient radiation exposure. These features align with best practices for fluoroscopy and radiographic imaging, ensuring procedures are conducted with the lowest effective dose possible while maintaining image clarity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CombiDiagnost R90 - Philips, PDF CombiDiagnost R90 1, Philips - CombiDiagnost R90 Funktionsübergreifendes DRF-System - Philips

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Philips Medical Systems DMC GmbH
EUDAMED SRN
DE-MF-000005362

Sources (3)

  • EUDAMED 9b625f2d-180b-427b-a73e-580358fed097 85 fields · synced Oct 6, 2026
  • FDA UDI 91178961-637b-4d36-9051-9bf30c2926bb 35 fields · synced May 30, 2026
  • FDA 510(k) K203087 1 fields · synced May 18, 2026