Cleared Traditional

K003438 - SMART RAD
(FDA 510(k) Clearance)

K003438 · Cmt Medical Technologies, Ltd. · Radiology

Jul 2001

Decision

239d

Days

Class 2

Risk

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

Submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 3, 2001, 239 days after receiving the submission on November 6, 2000.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K003438 FDA.gov
FDA Decision	Cleared 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