DRX - Ascend System

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: DRX - Ascend System FDA UDI
Generic Name: Diagnostic x-ray system generator, stationary FDA UDI
Device Name: 50 KW/125 KVP QUEST HF SE GEN FDA UDI
Model / Reference: DRX - Ascend System FDA UDI
Description: 50 KW/125 KVP QUEST HF SE GEN FDA UDI

Identifiers

Catalog Number: 1013853 FDA UDI
Primary DI / UDI-DI: 60889971013859 FDA UDI
FDA Product Code: IZO FDA UDI
GMDN Term: Diagnostic x-ray system generator, stationary FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1700 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Diagnostic x-ray system generator, stationary

DRX - Ascend System by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI ea71a0b4-315e-49fe-af5b-0ac407a50326 34 fields · synced Jun 8, 2026