WEB1000

FDA 510(k) K053458 · Agfa Corp.

Substantially Equivalent

510(k) numberK053458

Submission

Device name
WEB1000
Applicant
Agfa Corp.
Waterloo, Ontario, CA
Received
December 13, 2005
Decision date
December 22, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 WEB1000 cleared by the FDA?

WEB1000 (K053458) received a 510(k) decision of Substantially Equivalent on December 22, 2005, 9 days after the submission was received.

What is the product code of K053458?

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