Cleared Traditional

K011141 - SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC
(FDA 510(k) Clearance)

K011141 · Shimadzu Corp. · Radiology

Jul 2001

Decision

81d

Days

Class 2

Risk

K011141 is an FDA 510(k) clearance for the SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on July 3, 2001, 81 days after receiving the submission on April 13, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K011141 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2001
Decision Date	July 03, 2001
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement