Mobilett XP

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name: Mobilett XP FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name: Mobile Generator FDA UDI
Model / Reference: 01818363 FDA UDI
Description: Mobile Generator FDA UDI

Identifiers

Primary DI / UDI-DI: 04056869009087 FDA UDI
510(k) Number: K033238 FDA UDI
FDA Product Code: IZL FDA UDI
GMDN Term: Mobile basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

Mobilett XP by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SEDECAL — Sedecal., Sa. · Class II
DRX-Revolution Mobile X-ray System — CARESTREAM HEALTH, INC. · Class II

Cleared under the same submission

K033238 also covers:

Mobilett XP hybrid — Siemens Healthcare

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare

Sources (1)

FDA UDI b796e1b9-a974-480c-8b80-4a9c902485d8 35 fields · synced May 30, 2026