Cleared Special

K090683 - SYNGO RT THERAPIST CONNECT (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090683 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
53d
Days
Class 2
Risk

K090683 is an FDA 510(k) clearance for the SYNGO RT THERAPIST CONNECT. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on May 8, 2009 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K090683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2009
Decision Date May 08, 2009
Days to Decision 53 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Peers - IYE Accelerator, Linear, Medical

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