Cleared Traditional

ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION (K923077) - FDA 510(k) Clearance

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

K923077 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
222d
Days
Class 2
Risk

K923077 is an FDA 510(k) clearance for the ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on February 2, 1993 after a review of 222 days - an extended review 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: 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 GE Medical Systems devices

Submission Details

510(k) Number K923077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date February 02, 1993
Days to Decision 222 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
115d slower than avg
Panel avg: 107d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - JAK System, X-ray, Tomography, Computed

All 427
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K923077.
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985 · Siemens Medical Solutions USA, Inc. · Apr 1994
IMPAX 3000
K934832 · Heraeus Kulzer, Inc. · Dec 1993
PHILIPS TOMOSCAN SR7000 CT SYSTEMS
K924082 · Philips Medical Systems, Inc. · Mar 1993
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
K921192 · GE Medical Systems · Oct 1992
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108 · Cook, Inc. · Sep 1992
ADULT CHIN STRAP FOR CT TABLES
K923109 · Cook, Inc. · Sep 1992