Cleared Traditional

K082354 - STEREO NAVIGATOR ACCESSORY, STN-1000

K082354 is an FDA 510(k) clearance for STEREO NAVIGATOR ACCESSORY, manufactured by Naviscan Pet Systems. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K082354 · Naviscan Pet Systems · Radiology device
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Nov 2008
Decision
95d
Days
Class 2
Risk

K082354 is an FDA 510(k) clearance for the STEREO NAVIGATOR ACCESSORY, STN-1000. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Naviscan Pet Systems (San Diego, US). The FDA issued a Cleared decision on November 18, 2008 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Naviscan Pet Systems devices

FDA 510(k) Submission Details - K082354

510(k) Number K082354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date November 18, 2008
Days to Decision 95 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 107d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 321
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K082354.
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K082368 · Digirad Corp. · Sep 2008
PCA-8000A, MARK 11, PET / CT SYSTEM
K082244 · Toshiba America Medical Systems, In.C · Aug 2008
BIOGRAPH HD FAMILY
K081453 · Siemens Medical Solutions USA, Inc. · Jun 2008