Cleared Traditional

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 (K033001) - FDA 510(k) Clearance

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

K033001 · Transphoton Corporation · Radiology device
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Dec 2003
Decision
90d
Days
Class 2
Risk

K033001 is an FDA 510(k) clearance for the APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Transphoton Corporation (Lunenburg, US). The FDA issued a Cleared decision on December 24, 2003 after a review of 90 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 Transphoton Corporation devices

Submission Details

510(k) Number K033001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2003
Decision Date December 24, 2003
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 172
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K033001.
GE DISCOVERY ST SYSTEM
K041220 · GE Medical Systems · Jun 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · Siemens Medical Solutions USA, Inc. · May 2004
MODIFICATION TO GE DISCOVERY LS SYSTEM
K040172 · GE Medical Systems · Apr 2004
ALLEGRO IMAGING SYSTEM
K033782 · Philips Medical Systems (Cleveland), Inc. · Dec 2003
GEMINI 16
K032036 · Philips Medical Systems (Cleveland), Inc. · Jul 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · General Electric Co. · Feb 2003