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CS OMS Imaging Software

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
CS OMS Imaging Software FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation application software FDA UDI
Device Name
CS OMS Imaging Software FDA UDI
Model / Reference
CS OMS Imaging Software FDA UDI
Description
CS OMS Imaging Software FDA UDI

Identifiers

Catalog Number
1746841 FDA UDI
Primary DI / UDI-DI
60889971746849 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation application software.

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 97a8bd9e-f75c-4d26-97f7-1e618e8d2a6b 34 fields · synced Jun 8, 2026