IMPAX Agility

FDA 510(k) K142316 · Agfa Healthcare N.V.

Substantially Equivalent

510(k) numberK142316

Submission

Device name
IMPAX Agility
Applicant
Agfa Healthcare N.V.
Mortsel, BE
Received
August 19, 2014
Decision date
January 6, 2015
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 Agility cleared by the FDA?

IMPAX Agility (K142316) received a 510(k) decision of Substantially Equivalent on January 6, 2015, 140 days after the submission was received.

What is the product code of K142316?

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