Cleared Traditional

K827176 - MODEL 640 LINEAR SCANNER (FDA 510(k) Clearance)

Dec 1982
Decision
42d
Days
-
Risk

K827176 is an FDA 510(k) clearance for the MODEL 640 LINEAR SCANNER..

Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on December 14, 1982, 42 days after receiving the submission on November 2, 1982.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K827176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1982
Decision Date December 14, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -

Device Classification

Product Code -
Device Class -