Cleared Traditional

HISPEED ADVANTAGE II (K940606) - FDA 510(k) Clearance

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

K940606 · GE Medical Systems · Radiology device
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Aug 1994
Decision
194d
Days
Class 2
Risk

K940606 is an FDA 510(k) clearance for the HISPEED ADVANTAGE II. 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 August 23, 1994 after a review of 194 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 K940606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date August 23, 1994
Days to Decision 194 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
87d slower than avg
Panel avg: 107d · This submission: 194d
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 K940606.
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268 · Philips Medical Systems (Cleveland), Inc. · Jan 1996
PQ5000 CT SYSTEM
K943623 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
CT PROSPEED FAMILY
K944013 · GE Medical Systems · Feb 1995
TSX-002A (XVISION) CT SCANNER
K941745 · Toshiba America Medical Systems, In.C · Jul 1994
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524 · Siemens Medical Solutions USA, Inc. · May 1994
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985 · Siemens Medical Solutions USA, Inc. · Apr 1994