Model-Based Rsa Software

FDA 510(k) K133966 · Halifax Biomedical, Inc.

Substantially Equivalent

510(k) numberK133966

Submission

Device name
Model-Based Rsa Software
Applicant
Halifax Biomedical, Inc.
Naples, FL, US
Received
December 24, 2013
Decision date
March 6, 2014
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 Model-Based Rsa Software cleared by the FDA?

Model-Based Rsa Software (K133966) received a 510(k) decision of Substantially Equivalent on March 6, 2014, 72 days after the submission was received.

What is the product code of K133966?

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