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DRX-Rise Mobile X-ray System

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
DRX-Rise Mobile X-ray System FDA UDI
Generic Name
Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name
DRX-RISE MOBILE X-RAY SYSTEM FDA UDI
Model / Reference
DRX-Rise Mobile X-ray System FDA UDI
Description
DRX-RISE MOBILE X-RAY SYSTEM FDA UDI

Identifiers

Catalog Number
8626004 FDA UDI
Primary DI / UDI-DI
60889978626007 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

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

Yes

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

No

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

DRX-Rise Mobile X-ray System by Carestream Health, 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI 44b0caae-3fd0-42b1-be07-5b03eafccd51 35 fields · synced Jun 8, 2026