Uc-5000

FDA UDI

Class II (US FDA UDI)

by Source-Ray, Inc.

Identity

Trade Name: UC-5000 FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name: Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels FDA UDI
Model / Reference: UC-5000 FDA UDI
Description: Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels FDA UDI

Identifiers

Catalog Number: 900117 FDA UDI
Primary DI / UDI-DI: 00867538000304 FDA UDI
510(k) Number: K163063 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

Yes

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

Yes

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

Uc-5000 by Source-Ray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile basic diagnostic x-ray system, digital.

MobileDaRt Evolution — Shimadzu Corp. · Class II
Added filter — FUJIFILM Corporation · Class II
MinXray — Minxray, Inc. · Class II
SEDECAL — Sedecal., Sa. · Class II
MinXray — Minxray, Inc. · Class II
Transportation carriage — FUJIFILM Corporation · Class II
SEDECAL — Sedecal., Sa. · Class II
DRX-Revolution Mobile X-ray System — CARESTREAM HEALTH, INC. · Class II

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

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

Manufacturer

Manufacturer: Source-Ray, Inc.

Sources (1)

FDA UDI 6fffed1d-66ba-469a-a566-618fea1b325e 36 fields · synced May 30, 2026