Hexapod RT Couchtop

FDA 510(k) K041448 · Medical Intelligence Medizintechnik GmbH

Substantially Equivalent

510(k) numberK041448

Submission

Device name
Hexapod RT Couchtop
Applicant
Medical Intelligence Medizintechnik GmbH
Schwabmunchen, DE
Received
June 1, 2004
Decision date
June 16, 2004
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
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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More from Medical Intelligence Medizintechnik GmbH

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K143485iGuide 2.1IYE · Traditional 03/04/2015SE
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K112210FraxionIYE · Traditional 11/22/2011SE
K072898Hexapod Evo RT Couch TopJAI · Special 10/25/2007SE
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K030439HeadfixIYE · Traditional 05/08/2003SE
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Questions and answers

When was Hexapod RT Couchtop cleared by the FDA?

Hexapod RT Couchtop (K041448) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 15 days after the submission was received.

What is the product code of K041448?

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