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DRX-Evolution Plus System

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
DRX-Evolution Plus System FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
DRX EVO FIXD ELE TBL MDL VX3733-TAB FDA UDI
Model / Reference
DRX-Evolution Plus System FDA UDI
Description
DRX EVO FIXD ELE TBL MDL VX3733-TAB FDA UDI

Identifiers

Catalog Number
1016146 FDA UDI
Primary DI / UDI-DI
60889971016140 FDA UDI
510(k) Number
K091889 FDA UDI
FDA Product Code
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 FDA UDI
Commercial Distribution
Not 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

No

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

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

Cleared under the same submission

K091889 also covers:

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 9920bb46-554c-4632-8ebb-8a0f404a54de 36 fields · synced Jun 6, 2026