Cleared Special

K123917 - DECLIPSESPECT VIEWER (FDA 510(k) Clearance)

Class I Radiology device.

K123917 · Surgiceye GmbH · Radiology device
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Jan 2013
Decision
37d
Days
Class 1
Risk

K123917 is an FDA 510(k) clearance for the DECLIPSESPECT VIEWER. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Surgiceye GmbH (Munich, DE). The FDA issued a Cleared decision on January 25, 2013 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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 Surgiceye GmbH devices

Submission Details

510(k) Number K123917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date January 25, 2013
Days to Decision 37 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.