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ProxiDiagnost N90 1.1

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 706110510(k) K173433

by Philips Medical Systems DMC GmbH

Identity

Trade Name
ProxiDiagnost N90 1.1 EUDAMED
ProxiDiagnost N90 FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
Nearby DRF-System EUDAMED
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • 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 • 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 • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large FDA UDI
Model / Reference
706110 EUDAMEDFDA UDI
Description
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • 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 • 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 • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large FDA UDI

Identifiers

Primary DI / UDI-DI
00884838103221 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM441SU EUDAMED
FDA Product Code
JAA FDA UDI
KPR FDA UDI
EMDN Code
Z11039009 FLUOROSCOPY DEVICES EUDAMED
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
892.1680 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

No

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

Yes

FDA UDI

ProxiDiagnost N90 1.1 by Philips Medical Systems DMC GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

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

Sources (3)

  • EUDAMED 001a3994-e4c5-45a3-a4fd-330f3f672c1f 85 fields · synced Jun 19, 2026
  • FDA UDI 84a016c4-49c8-4a37-8ae5-0a6a042de282 33 fields · synced May 29, 2026
  • FDA 510(k) K212837 1 fields · synced May 18, 2026