Impax Client Embrace

FDA 510(k) K040555 · Agfa Corp.

Substantially Equivalent

510(k) numberK040555

Submission

Device name
Impax Client Embrace
Applicant
Agfa Corp.
Waterloo, Ontario, CA
Received
March 2, 2004
Decision date
May 26, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Impax Client Embrace cleared by the FDA?

Impax Client Embrace (K040555) received a 510(k) decision of Substantially Equivalent on May 26, 2004, 85 days after the submission was received.

What is the product code of K040555?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.