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Change Healthcare Stratus Imaging PACS

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K241981

by Change Healthcare Canada Company

Identity

Trade Name
Change Healthcare Stratus Imaging PACS FDA UDI
Generic Name
Radiological PACS software FDA UDI
Model / Reference
1.7.0 FDA UDI

Identifiers

Primary DI / UDI-DI
17540262160185 FDA UDI
510(k) Number
K241981 FDA 510(k)FDA UDI
FDA Product Code
LLZ FDA 510(k)FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)FDA UDI
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Change Healthcare Stratus Imaging PACS by Change Healthcare Canada Company — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Change Healthcare Canada Company

Sources (2)

  • FDA 510(k) K241981 24 fields · synced Jun 18, 2026
  • FDA UDI 05e3a598-3f18-495a-9fa9-c3486d49bd37 33 fields · synced May 27, 2026