← Back to catalogue

Xr-Mx/1000

FDA UDI

Class II (US FDA UDI)

by Storz Medical AG

Identity

Trade Name
XR-MX/1000 FDA UDI
Generic Name
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI
Device Name
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures. FDA UDI
Model / Reference
FD43 (80 kW) FDA UDI
Description
The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures. FDA UDI

Identifiers

Catalog Number
29255 FDA UDI
Primary DI / UDI-DI
07630039101046 FDA UDI
510(k) Number
K200965 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Stationary uro-gynaecological fluoroscopic x-ray system, digital

Xr-Mx/1000 by Storz Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary uro-gynaecological fluoroscopic x-ray system, digital.

Cleared under the same submission

K200965 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Storz Medical AG

Sources (1)

  • FDA UDI 6be43fe0-67f1-453c-a998-69c6db6f2165 35 fields · synced Jun 1, 2026