Cleared Traditional

K022794 - E-SPEED EBT SCANNER SYSTEM

K022794 is an FDA 510(k) clearance for E-SPEED EBT SCANNER SYSTEM, manufactured by Ge Imatron. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K022794 · Ge Imatron · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
49d
Days
Class 2
Risk

K022794 is an FDA 510(k) clearance for the E-SPEED EBT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Imatron (South San Fransisco, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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.

FDA 510(k) Submission Details - K022794

510(k) Number K022794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date October 11, 2002
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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

Tuv Rheinland of North America, Inc.
NISHITH DESAI

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 - JAK System, X-ray, Tomography, Computed

All 823
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K022794.
SOMATOM EMOTION 6 CT SYSTEMS
K023687 · Siemens Medical Systems, Inc. · Nov 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · Toshiba America Medical Systems, In.C · Nov 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · GE Medical Systems · Oct 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · GE Medical Systems · Sep 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239 · Praxim · Aug 2002
ULTRAGUIDE CTG 2000SA
K022354 · Ultraguide , Ltd. · Aug 2002
K022794 · E-SPEED EBT SCANNER SYSTEM
Download PDF FDA Summary Ge Imatron