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Change Healthcare Enterprise Imaging Network Viewer

FDA UDI

Class II (US FDA UDI)

by Change Healthcare Canada Company

Identity

Trade Name
Change Healthcare Enterprise Imaging Network Viewer FDA UDI
Generic Name
Radiological PACS software FDA UDI
Model / Reference
1.0.1 FDA UDI

Identifiers

Primary DI / UDI-DI
17540262130027 FDA UDI
510(k) Number
K181185 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Change Healthcare Enterprise Imaging Network Viewer by Change Healthcare Canada Company — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K181185 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Change Healthcare Canada Company

Sources (1)

  • FDA UDI 21107e3a-3f0f-4eb5-b030-416d973e02ea 34 fields · synced Jun 8, 2026