Cleared Special

K062639 - MODIFICATION TO HEXAPOD RT COUCH TOP

K062639 is an FDA 510(k) clearance for MODIFICATION TO HEXAPOD RT COUCH TOP, manufactured by Medical Intelligence Medizintechnik-GmbH-An Elekta. The device is a Class 2 Radiology device with product code JAI cleared through the Special 510(k) pathway after a 15-day FDA review.

K062639 · Medical Intelligence Medizintechnik-GmbH-An Elekta · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
15d
Days
Class 2
Risk

K062639 is an FDA 510(k) clearance for the MODIFICATION TO HEXAPOD RT COUCH TOP. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Medical Intelligence Medizintechnik-GmbH-An Elekta (Schwabmunchen, DE). The FDA issued a Cleared decision on September 21, 2006 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062639

510(k) Number K062639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date September 21, 2006
Days to Decision 15 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAI Couch, Radiation Therapy, Powered

All 29
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K062639.
QFIX RADIOTHERAPY CHAIR
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AVANZA
K060870 · Mds Nordion · May 2006
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K060671 · Wfr/Aquaplast Corp. · May 2006
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K050422 · Siemens Medical Solutions USA, Inc. · Mar 2005
K062639 · MODIFICATION TO HEXAPOD RT COUCH TOP
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