Cleared Traditional

K965226 - EXPERT-XL TOTAL BODY ACQUISITION AND AN...

K965226 is an FDA 510(k) clearance for EXPERT-XL TOTAL BODY ACQUISITION AND AN..., manufactured by Lunar Corp.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K965226 · Lunar Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
277d
Days
Class 2
Risk

K965226 is an FDA 510(k) clearance for the EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Lunar Corp. (Madison, US). The FDA issued a Cleared decision on October 3, 1997 after a review of 277 days - an extended review cycle.

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 Lunar Corp. devices

FDA 510(k) Submission Details - K965226

510(k) Number K965226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1996
Decision Date October 03, 1997
Days to Decision 277 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 107d · This submission: 277d
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 250
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K965226.
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · Adac Laboratories · May 1998
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories · Nov 1997
MCD-AC
K971980 · Adac Laboratories · Oct 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc. · Sep 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · Siemens Medical Solutions USA, Inc. · Sep 1997
VANTAGE 2.1 EXSPECT
K971878 · Adac Laboratories · Aug 1997