Protura Couch Software

FDA 510(k) K122201 · Med-Tec, Inc. D/B/A Civco Medical Solutions

Substantially Equivalent

510(k) numberK122201

Submission

Device name
Protura Couch Software
Applicant
Med-Tec, Inc. D/B/A Civco Medical Solutions
Orange City, IA, US
Received
July 25, 2012
Decision date
August 30, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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Questions and answers

When was Protura Couch Software cleared by the FDA?

Protura Couch Software (K122201) received a 510(k) decision of Substantially Equivalent on August 30, 2012, 36 days after the submission was received.

What is the product code of K122201?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.