Cleared Special

K083035 - DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (FDA 510(k) Clearance)

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

K083035 · Sicel Technologies, Inc. · Radiology device
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Nov 2008
Decision
30d
Days
Class 2
Risk

K083035 is an FDA 510(k) clearance for the DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM. Classified as Dosimeter, Ionizing Radiation, Implanted (product code NZT), Class II - Special Controls.

Submitted by Sicel Technologies, Inc. (Morrisville, US). The FDA issued a Cleared decision on November 13, 2008 after a review of 30 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 Sicel Technologies, Inc. devices

Submission Details

510(k) Number K083035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date November 13, 2008
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NZT Dosimeter, Ionizing Radiation, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
Definition Verify Radiation Dose To Organs From External Radiation Therapy.
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.