Cleared Traditional

K023932 - GE PHOTON ENERGY RECOVERY (PER) OPTION

K023932 is an FDA 510(k) clearance for GE PHOTON ENERGY RECOVERY (PER) OPTION, manufactured by Ge Medical Systems F.I. Haifa. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K023932 · Ge Medical Systems F.I. Haifa · Radiology device
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Dec 2002
Decision
15d
Days
Class 2
Risk

K023932 is an FDA 510(k) clearance for the GE PHOTON ENERGY RECOVERY (PER) OPTION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 11, 2002 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems F.I. Haifa devices

FDA 510(k) Submission Details - K023932

510(k) Number K023932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date December 11, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 404
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K023932.
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ECAT LSO PET/CT 16
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