Cleared Traditional

K003438 - SMART RAD

K003438 is an FDA 510(k) clearance for SMART RAD, manufactured by Cmt Medical Technologies, Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K003438 · Cmt Medical Technologies, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
239d
Days
Class 2
Risk

K003438 is an FDA 510(k) clearance for the SMART RAD. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 3, 2001 after a review of 239 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

FDA 510(k) Submission Details - K003438

510(k) Number K003438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date July 03, 2001
Days to Decision 239 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
132d slower than avg
Panel avg: 107d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K003438.
ADC PEDIATRIC
K012750 · Agfa Corp. · Nov 2001
SOLID STATE X-RAY IMAGING DEVICES
K003238 · Cares Built, Inc. · Oct 2001
ADC COMPACT PLUS
K013138 · Agfa-Gevaert AG · Sep 2001
PHORMAX EAGLE SCANNER SYSTEM
K001499 · Phormax Corp. · Dec 2000
PCCR DIGITAL IMAGING DEVICE
K003256 · Orex Computed Radiography, Ltd. · Nov 2000
XPLORER 1000
K992955 · Imaging Dynamics Corp. · Jun 2000
K003438 · SMART RAD
Download PDF FDA Summary Cmt Medical Technolog…