Cleared Traditional

K837107 - SOMATOM DRI X-RAY CT SCANNER (FDA 510(k) Clearance)

Mar 1983
Decision
37d
Days
Risk

K837107 is an FDA 510(k) clearance for the SOMATOM DRI X-RAY CT SCANNER..

Submitted by Siemens Medical Solutions USA, Inc. (Issaquah, US). The FDA issued a Cleared decision on March 9, 1983, 37 days after receiving the submission on January 31, 1983.

This device falls under the Radiology FDA review panel.

Submission Details

510(k) Number K837107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date March 09, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class