Cleared Traditional

EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE (K965226) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K965226 · Lunar Corp. · Radiology device
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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

Submission Details

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
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.

Device Classification

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 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K965226.
TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
K983516 · Toshiba America Medical Systems, In.C · Dec 1998
E.CAM EXTRA HIGH ENERGY COLLIMATOR
K982387 · Siemens Medical Solutions USA, Inc. · Oct 1998
TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A
K982300 · Toshiba America Medical Systems, In.C · Sep 1998
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
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997