Alphapoint Imaging Software

FDA 510(k) K120161 · Radlogics, Inc.

Substantially Equivalent

510(k) numberK120161

Submission

Device name
Alphapoint Imaging Software
Applicant
Radlogics, Inc.
Los Gatos, CA, US
Received
January 19, 2012
Decision date
April 13, 2012
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 Alphapoint Imaging Software cleared by the FDA?

Alphapoint Imaging Software (K120161) received a 510(k) decision of Substantially Equivalent on April 13, 2012, 85 days after the submission was received.

What is the product code of K120161?

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