Cleared Traditional

K950667 - AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER

K950667 is an FDA 510(k) clearance for AZTECH 65 WITH CCD (COMPUTER CONTROLLED..., manufactured by Chicago X-Ray Systems, Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K950667 · Chicago X-Ray Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
52d
Days
Class 2
Risk

K950667 is an FDA 510(k) clearance for the AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Chicago X-Ray Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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 Chicago X-Ray Systems, Inc. devices

FDA 510(k) Submission Details - K950667

510(k) Number K950667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date April 06, 1995
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 8
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K950667.
ATLANTIS
K953936 · Trophy Radiologie · Dec 1995
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
K950533 · Trophy Radiologie · Jun 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
PORTARAY
K792535 · Siemens Corp. · Jan 1980
RAFLEX 70
K792437 · Mdt Corp., Inc. · Jan 1980
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · General Electric Co. · Dec 1978