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ImageXL

FDA UDI

Class II (US FDA UDI)

by Professional Economics Bureau Of America Inc

Identity

Trade Name
ImageXL FDA UDI
Generic Name
General-purpose dental x-ray system application software FDA UDI
Device Name
IMAGEXL XRAY SOFTWARE VERSION 4 BASE FDA UDI
Model / Reference
4 FDA UDI
Description
IMAGEXL XRAY SOFTWARE VERSION 4 BASE FDA UDI

Identifiers

Primary DI / UDI-DI
00861787000306 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
General-purpose dental x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose dental x-ray system application software

ImageXL by Professional Economics Bureau Of America Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose dental x-ray system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Professional Economics Bureau Of America Inc

Sources (1)

  • FDA UDI 761bf0e0-63a2-438e-8589-5a3824ea94bf 33 fields · synced May 30, 2026